/H5:2'/t 


B.  A.  I.  Order  276. 


Ol     M 


U.S.  DEPOSITORY 


Issued  October  10.  1922. 


UNITED  STATES  DEPARTMENT  OF  AGRICULTURE. 

Bureau  of  Animal  Industry. 
JOHN  R.  MOHLER,  Chief  of  Bureau. 


REGULATIONS  GOVERNING  THE  PREPARATION,  SALE,  BARTER, 
EXCHANGE,  SHIPMENT,  AND  IMPORTATION  OF  VIRUSES, 
SERUMS,  TOXINS,  AND  ANALOGOUS  PRODUCTS  INTENDED  FOR 
USE  IN  THE  TREATMENT  OF  DOMESTIC  ANIMALS. 

Effective  on  and  after  November  i,  1922. 


CONTENTS. 

Page. 

Regulation    1.  Definitions 2 

Regulation    2.   Licenses   and    inspections 3 

Regulation    3.   Permits 5 

Regulation    4.   Suspension  or  revocation  of  licenses  and  permits 6 

Regulation    5.   Notice  to  licensees  and  permittees 7 

Regulation    6.  Assignment  of  bureau  employees 7 

Regulation    7.  Facilities    for   inspection 7 

Regulation    8.   Sanitation 7 

Regulation    9.   Sterilization 9 

Regulation  10.   Storage 10 

Regulation  11.   Records 10 

Regulation  12.  Labels 10 

Regulation  13.   Collecting    samples 12 

Regulation  14.   Production,  testing,   etc 12 

Regulation  15.  Retesting 12 

Regulation  16.   Reports 13 

Regulation  17.  Animals 13 

Regulation  18.  Hog-cholera   virus 18 

Regulation  19.  Anti-hog-cholera    serum 23 

Regulation  20.  Bacterins.  vaccines,  toxins,  etc 33 

Regulation  21.  Admission  of  viruses,  serums,  toxins,  and  analogous  products 34 

The  virus-serum-toxin  law 34 


U.  S.  Department  of  Agriculture, 

Office  of  the  Secretary, 
Washington,  D.  C,  August  i<5,  1922. 
Under  authority  of  the  act  of  Congress  approved  March  4,  1913. 
entitled  "  An  act  making  appropriations  for  the  Department  of 
Agriculture  for  the  fiscal  year  ending  June  30.  1914"  (37  Stat. 
832),  the  following  regulations  are  hereby  issued  for  the  purpose 
of  enforcing  the  provisions  of  said  act  governing  the  preparation, 
sale,  barter,  exchange,  shipment,  and  importation  of  viruses,  serums, 
toxins,  and  analogous  products  intended  for  use  in  the  treatment 
of  domestic  animals.  These  regulations,  which  for  the  purpose  of 
identification  are  designated  as  B.  A.  I.  Order  276.  shall  become 
and  be  effective  on  and  after  November  1.  1922.  except  that  any 
establishment  may  until  December  31,  1922,  continue  to  use  the 
phrase  "U.  S.  Released"  on  its  products  in  the  manner  provided 
for  the  use  thereof  in  B.  A.  I.  Order  265. 

Henry  C.  Wallace. 
Secretary  of  Agriculture. 


8177—22- 


REGULATION   i.— DEFINITIONS. 

Section  1.  Paragraph  1.  For  the  purpose  of  these  regulations, 
the  following  words,  phrases,  names,  and  terms  shall  be  construed, 
respectively,  to  mean: 

Paragraph  2.  The  virus-serum-toxin  act  of  1913 :  "  An  act  mak- 
ing appropriations  for  the  Department  of  Agriculture  for  the 
fiscal  year  ending  June  30,  1914,"  approved  March  4.  1913  (37 
Stat.  832). 

Paragraph  3.  Viruses,  serums,  toxins,  and  analogous  products, 
or  veterinary  biologies:  All  viruses,  serums,  toxins,  and  analogous 
products,  such  as  antitoxins,  vaccines,  tuberculins,  malleins,  live 
microorganisms,  killed  microorganisms,  or  bacterins,  and  products 
of  microorganisms  which  are  intended  for  use  in  the  treatment  of 
domestic  animals. 

Paragraph  4-  The  department :  The  United  States  Department  of 
Agriculture. 

Paragraph  5.  The  bureau:  The  Bureau  of  Animal  Industry  of 
the  United  States  Department  of  Agriculture. 

Paragraph  6.  Bureau  employee :  Any  officer,  agent,  or  other  indi- 
vidual employed  in  the  Bureau  of  Animal  Industry  who  is  au- 
thorized by  the  chief  of  the  bureau  to  do  an}'  work  or  perform  any 
duty  in  connection  with  the  execution  of  the  provisions  of  the 
virus-serum-toxin  act  of  1913. 

Paragraph  7.  Veterinary  inspector:  A  veterinary  inspector  of 
the  Bureau  of  Animal  Industry. 

Paragraph  8.  Lay  inspector:  A  lay  inspector  of  the  Bureau  of 
Animal  Industry. 

Paragraph  9.  Licensed  establishment:  Any  establishment  owned 
or  operated  by  a  person,  firm,  or  corporation  holding  an  unexpired, 
unsuspended,  and  unrevoked  license  issued  by  the  Secretary  of 
Agriculture  for  the  preparation  of  any  virus,  serum,  toxin,  or 
analogous  product. 

Paragraph  10.  Official  station:  One  or  more  licensed  establish- 
ments included  under  a  single  supervision. 

Paragraph  11.  Inspector  in  charge :  An  inspector  assigned  to 
supervise  and  perform  official  work  at  an  official  station  and  who 
reports  directly  to  the  chief  of  the  bureau. 

Paragraph  12.  Person:  Natural  persons,  individuals,  firms,  part- 
nerships, corporations,  companies,  societies,  and  associations  and 
every  agent,  officer,  or  employee  of  any  thereof.  This  term  shall 
import  both  the  plural  and  the  singular,  as  the  case  may  be. 

Paragraph  13.  Hog-cholera  virus :  The  clear  serum,  plasma,  or 
defibrinated  blood  derived  from  pigs  sick  of  hog  cholera  and  free 
from  other  communicable  disease  or  diseases. 

Paragraph  H.  Hyperimmunizing  virus:  Hog-cholera  virus  pre- 
pared for  hyperimmunizing  hogs  which  are  immune  to  hog  cholera. 

Paragraph  15.  Simultaneous  virus :  Hog-cholera  virus  prepared 
for  inoculating  hogs  which  are  to  be  injected  simultaneously  with 
anti-hog-cholera  serum  for  the  immunization  of  those  animals 
against  hog  cholera. 

Paragraph  16.  Anti-hog-cholera  serum:  The  clear  serum,  plasma. 
or  defibrinated  blood,  or  derivatives  thereof,  containing  the  protec- 
tive principles  derived  from  immune  hogs  which  have  been  hyperim- 


munized  by  an  intravenous  injection  of  at  least  5  cubic  centimeters, 
per  pound  body  weight,  of  the  virus  of  hog  cholera. 

Paragraph  17.  Immediate  or  true  container :  The  unit,  bottle,  vial, 
ampul,  tube,  or  other  receptacle,  or  container  in  which  any  virus, 
serum,  toxin,  or  analogous  product  is  customarily  sold  or  distributed. 

Paragraph  18.  Serial  number:  The  number  given  each  batch  of 
virus,  serum,  toxin,  or  analogous  product  to  identify  the  said  virus, 
serum,  toxin,  or  analogous  product  with  the  records  of  preparation 
thereof. 

Paragraph  19.  Return  date :  The  date  placed  upon  trade  labels 
affixed  to  or  used  in  connection  with  immediate  or  true  containers  of 
viruses,  serums,  toxins,  and  analogous  products  by  producers  to  in- 
dicate the  limit  of  time  during  which  the  said  products  may  be  ex- 
pected to  retain  their  full  strength  or  potency. 

Paragraph  20.  U.  S.  Released :  That  veterinary  biologies  so 
marked  have  been  prepared  and  tested  in  accordance  with  the  pro- 
visions of  these  regulations  and  that  when  thus  prepared,  tested,  and 
marked,  they  were  not  found  to  be  worthless,  contaminated,  danger- 
ous, or  harmful. 

REGULATION  2.— LICENSES  AND  INSPECTIONS. 

Section  1.  Every  establishment  in  the  United  States  at  which  any 
virus,  serum,  toxin,  or  analogous  product  is  prepared  for  sale,  barter, 
or  exchange  in  the  District  of  Columbia  or  in  any  Territory  of  or 
place  under  the  jurisdiction  of  the  United  States,  or  for  shipment 
or  delivery  for  shipment  from  any  State  or  Territory  or  the  District 
of  Columbia  to  any  other  State  or  Territory  or  the  District  of 
Columbia,  shall  hold  an  unexpired,  unsuspended,  and  unrevoked 
license,  issued  by  the  Secretary  of  Agriculture,  and  shall  have  in- 
spection under  these  regulations. 

Section  2.  All  viruses,  serums,  toxins,  and  analogous  products 
produced  at  licensed  establishments  shall  be  prepared,  handled, 
stored,  marked,  received  for  transportation,  and  transported  as  re- 
quired by  these  regulations. 

Section  3.  Paragraph  1.  The  proprietor  or  operator  of  each  estab- 
lishment of  the  kind  specified  in  section  1  of  this  regulation  shall 
make  application  in  writing  to  the  Secretary  of  Agriculture  for  a 
license.  When  one  proprietor  conducts  more  than  one  establish- 
ment, a  separate  application  shall  be  made  for  a  license  for  each 
establishment.  Blank  forms  of  application  will  be  furnished  upon 
request  addressed  to  the  Bureau  of  Animal  Industry,  Washington, 
D.  C. 

Paragraph  2.  Triplicate  copies  of  plans,  properly  drawn  to  scale, 
and  of  specifications,  including  plumbing  and  drainage  of  estab- 
lishments, together  with  triplicate  copies  of  all  labels  and  advertis- 
ing matter  to  be  used  in  connection  with  or  relating  to  all  viruses, 
serums,  toxins,  and  analogous  products  prepared  therein,  shall  ac- 
company the  application  for  a  license,  unless  these  plans,  specifica- 
tions, labels,  and  advertising  matter  have  already  been  approved  in 
writing  by  the  bureau. 

Paragraph  3.  In  case  of  change  in  ownership  or  location  while  an 
application  is  pending,  or  after  a  license  has  been  issued,  a  new  appli- 
cation shall  be  made. 


Section  4.  Paragraph  1.  A  license  will  not  be  issued  unless  the 
condition  of  the  establishment  and  the  methods  of  preparation  are 
such  as  reasonably  to  insure  that  the  products  will  accomplish  the 
object  for  which  they  are  intended  and  that  they  are  not  worthless, 
contaminated,  dangerous,  or  harmful. 

Paragraph  2.  A  license  will  not  be  issued  unless  and  until  the 
establishment  is  prepared  to  operate  under  the  direct  supervision  of 
a  competent  person  trained  in  bacteriological  technic  or  in  the  prep- 
aration of  viruses,  serums,  toxins,  or  analogous  products  named  in 
the  application. 

Paragraph  3.  A  license  will  not  be  issued  for  the  preparation  of 
any  virus,  serum,  toxin,  or  analogous  product  if  advertised  so  as  to 
mislead  or  deceive  the  purchaser,  or  if  the  package  or  container  in 
which  the  same  is  intended  to  be  sold,  bartered,  exchanged,  or  shipped 
bears  or  contains  any  statement,  design,  or  device  which  is  false  or 
misleading  in  any  particular. 

Section  5.  Paragraph  1.  A  license  will  be  issued  only  after  inspec- 
tion of  the  establishment  by  a  bureau  employee  has  shown  that  the 
condition  and  equipment  of  the  establishment  and  the  methods  of 
preparing,  handling,  and  storing  products  are  in  conformity  with 
these  regulations. 

Paragraph  2.  Licenses  shall  be  numbered  and  shall  be  in  the  fol- 
lowing form : 

United  States  Veterinary  License  No.  ■ . 


Washington,  D.  C, ,  19 

This  is  to  certify  that,  pursuant  to  the  terms  of  the  act  of  Congress  approved 
March  4,  1913  (37  Stat.  832),  governing  the  preparation,  sale,  barter,  exchange, 
shipment,  and  importation  of  viruses,  serums,  toxins,  and  analogous  products 

intended  for  use  in  the  treatment  of  domestic  animals, 

is  hereby  licensed  to  maintain  at an  establishment  for 

the  preparation  of . 

This  license  is  subject  to  termination  as  provided  in  the  regulations  made 
under  the  authority  contained  in  said  act  approved  March  4,  1913,  and  also 
to  suspension  or  revocation  if  the  licensee  violates  or  fails  to  comply  with  any 
provision  of  the  said  act  or  the  regulations  made  thereunder. 


Secretary  of  Agriculture. 
Countersigned  : 


Chief,  Bureau  of  Animal  Industry. 

Paragraph  3.  Two  or  more  licenses  may  bear  the  same  number 
when  they  are  issued  to  firms  under  the  same  ownership  or  control, 
provided  a  serial  letter  is  added  when  necessary,  to  identify  each 
license. 

Paragraph  4-  Should  a  licensed  establishment  discontinue  the  pro- 
duction of  any  virus,  serum,  toxin,  or  analogous  product,  the  license 
of  such  establishment  shall  be  returned  to  the  bureau  for  termina- 
tion and  a  new  license  issued  covering  such  products  named  therein 
as  the  establishment  shall  continue  to  produce.  Should  an  establish- 
ment be  engaged  in  the  preparation  of  products  under  a  number  of 
licenses  issued  from  time  to  time  by  the  department,  the  licenses 
shall  be  returned  to  the  bureau  at  its  request  for  termination  and  a 
new  license  issued  covering  all  the  products  embraced  in  the  returned 
licenses  which  the  establishment  shall  continue  to  produce. 


Section  6.  Paragraph  1.  No  viruses,  serums,  toxins,  or  analogous 
products  shall  be  prepared  in  whole  or  in  part  in  a  licensed  estab- 
lishment by  any  other  licensed  establishment  unless  authorized  in 
advance  by  the  chief  of  bureau. 

Paragraph  2.  Each  licensed  establishment  shall  be  separate  and 
distinct  from  any  unlicensed  establishment  in  which  any  virus, 
serum,  toxin,  or  analogous  product  is  prepared  or  handled. 

Paragraph  3.  When  a  license  is  issued  the  bureau  shall  inform  the 
proprietor  or  operator  of  the  establishment  of  the  requirements  of 
these  regulations.  If  the  establishment,  at  the  time  the  license  is 
,  issued,  has  in  possession  any  viruses,  serums,  toxins,  or  analogous 

products,  which  have  not  theretofore  been  prepared  and  of  which 
the  containers  have  not  been  theretofore  marked  in  compliance  with 
these  regulations,  the  identity  of  the  same  shall  be  maintained  and 
they  shall  not  be  shipped  or  delivered  for  shipment  from  one  State 
or  Territory  or  the  District  of  Columbia  to  another  State  or  Terri- 
tory or  the  District  of  Columbia,  or  otherwise  dealt  with  as  products 
prepared  under  these  regulations.  The  establishment  shall  adopt 
and  enforce  all  necessary  measures  and  shall  comply  with  all  such 
directions  as  the  chief  of  bureau  may  prescribe  for  carrying  out  the 
purposes  of  this  paragraph. 

REGULATION  3.— PERMITS. 

Section  1.  Each  importer  of  viruses,  serums,  toxins,  or  analogous 
products  shall  hold  an  unexpired,  unsuspended,  and  unrevoked  per- 
mit issued  by  the  Secretary  of  Agriculture. 

Section  2.  Paragraph  1.  Each  importer  of  viruses,  serums,  toxins, 
and  analogous  products  shall  make  application  in  writing  to  the 
Secretary  of  Agriculture  for  a  permit.  The  application  shall  specify 
the  port  or  ports  of  entry  at  which  the  imported  articles  will  be 
cleared  through  the  customs.  Blank  forms  of  application  will  be 
furnished  upon  request  addressed  to  the  Bureau  of  Animal  Industry, 
Washington,  D.  C. 

Paragraph  2.  Each  application  for  a  permit  shall  be  accompanied 
by  the  affidavit  of  the  actual  manufacturer  produced  before  an 
American  consular  officer,  giving  the  city  or  town  where  the  viruses, 
serums,  toxins,  or  analogous  products  mentioned  therein  are  pre- 
pared, and  stating  that  said  products  are  not  worthless,  contami- 
nated, dangerous,  or  harmful;  whether  the  products  were  derived 
from  animals,  and,  if  so  derived,  the  name  of  the  species,  and  that 
such  animals  have  not  been  exposed  to  any  infectious  or  contagious 
disease,  except  as  ma}^  have  been  essential  in  the  preparation  of  the 
products  and  as  specified  in  the  affidavit. 

Paragraph  3.  Each  application  for  a  permit  shall  be  accompanied 
by  the  written  consent  of  the  actual  manufacturer  that  properly 
accredited  employees  of  the  department  shall  have  the  privilege  of 
inspecting,  without  previous  notification,  all  parts  of  the  establish- 
ment at  which  such  viruses,  serums,  toxins,  or  analogous  products  are 
prepared,  and  all  processes  of  and  all  records  kept  relative  to  the 
preparation  of  such  products  at  such  times  as  may  be  demanded  by 
the  aforesaid  employees. 

Paragraph  4-  Each  application  for  permit  shall  be  accompanied 
by  triplicate  copies  of  all  labels  and  advertising  matter. 


Section  3.  A  permit  will  not  be  issued  for  the  importation  of  any 
viruses,  serums,  toxins,  or  analogous  products  if  advertised  so  as 
to  mislead  or  deceive  the  purchaser,  or  if  the  package  or  container 
in  which  the  same  is  intended  to  be  sold,  bartered,  exchanged,  shipped, 
or  imported  bears  or  contains  any  statement,  design,  or  device  which 
is  false  or  misleading  in  any  particular. 

Section  4.  Paragraph  1.  Permits  shall  be  numbered  and  shall  be 
in  the  following  form : 

United  States  Veterinary  Permit  No. 

Washington,  D.  C .  19— 

This  is  to  certify  that,  pursuant  to  the  terms  of  the  act  of  Congress  approved 
March  4.  1913  (37  Stat.  832),  governing  the  preparation,  sale,  barter,  exchange, 
shipment,  and  importation  of  viruses,  serums,  toxins,  and  analogous  products 

intended  for  use  in  the  treatment  of  domestic  animals, , 

State  of is  hereby  authorized,  so  far  as  the  jurisdic- 
tion of  the  Department  of  Agriculture  is  concerned,  to  import 

manufactured  by ,  of ,  into 

the  United   States  through. the  port  of  during  the 

calendar  year  19 

This  permit  is  subject  to  suspension  or  revocation  if  the  permittee  violates 
or  fails  to  comply  with  the  provisions  of  the  said  act  approved  March  4.  1913, 
or  of  the  regulations  made  thereunder. 


Secretary  of  Agriculture. 
Countersigned : 


Chief,  Bureau  of  Animal  Industry. 
Paragraph  2.  Each  permit  shall  terminate  at  the  end  of  the  cal- 
endar year  for  which  it  is  issued. 

REGULATION    4.— SUSPENSION    OR    REVOCATION    OF    LICENSES    AND 

PERMITS. 

Section  1.  Licenses  or  permits  ma}T  be  suspended  or  revoked  after 
opportunity  for  hearing  has  been  accorded  the  licensee  or  permittee 
if  it  appears — 

(1)  That  the  construction  of  the  establishment  in  which  the 
viruses,  serums,  toxins,  or  analogous  products  are  prepared  is  defec- 
tive, or  that  the  establishment  is  improperly  conducted ; 

(2)  That  the  methods  of  preparation  are  faulty,  or  that  the  said 
products  contain  impurities  or  lack  potency : 

(3)  That  the  products  are  labeled  so  as  to  mislead  or  deceive  the 
purchaser  in  any  particular: 

(4)  That  the  license  or  permit  is  used  to  facilitate  or  effect  the 
preparation,  sale,  barter,  exchange,  shipment,  or  importation  of  any 
worthless,  contaminated,  dangerous,  or  harmful  viruses,  serums, 
toxins,  or  analogous  products :  or    . 

(5)  That  the  licensee  or  permittee  has  violated  or  failed  to  comply 
with  any  provision  of  the  virus-serum-toxin  act  of  1913.  or  01  the 
rules  and  regulations  made  thereunder. 

Section  2.  All  hearings  shall  be  private  and  at  times  and  places 
designated  by  the  Secretary  of  Agriculture.  The  parties  interested 
may  appear  in  person  or  by  attorney,  and  may  submit  oral  or  written 
evidence  on  the  questions  involved.  Upon  request  and  by  paying  the 
cost,  the  person  involved  will  be  furnished  with  a  copy  of  the  trans- 
script  of  the  hearing. 


REGULATION  5.— NOTICE  TO   LICENSEES  AND   PERMITTEES. 

Section  1.  If  at  any  time  it  appears  that  the  preparation,. sale, 
barter,  exchange,  shipment,  or  importation  of  any  virus,  serum,  toxin, 
or  analogous  product  by  any  person  holding  a  license  or  permit  may 
be  dangerous  in  the  treatment  of  domestic  animals,  the  Secretary  of 
Agriculture  will  so  notify  the  licensee  or  permittee,  and  unless  and 
until  the  Secretary  of  Agriculture  shall  otherwise  direct,  no  person, 
so  notified,  shall  thereafter  prepare,  sell,  barter,  or  exchange,  nor 
shall  thereafter  ship,  offer  for  shipment,  or  import  any  of  such 
product. 

REGULATION  6.— ASSIGNMENT   OF  BUREAU   EMPLOYEES. 

Section  1.  Any  bureau  employee,  as  defined  in  these  regulations, 
shall  be  permitted  to  enter  any  establishment  licensed  under  these 
regulations  at  any  hour  during  the  daytime  or  nighttime ;  and  such 
bureau  employee  shall  be  permitted  to  inspect  without  previous  noti- 
fication the  entire  premises  of  the  establishment,  including  all  build- 
ings, compartments,  and  other  places,  and  all  equipment,  such  as 
chemicals,  instruments,  apparatus,  and  the  like,  as  well  as  the  meth- 
ods used  in  the  manufacture  of,  and  all  records  maintained  relative 
to.  viruses,  serums,  toxins,  or  analogous  products. 

Section  2.  Eadi  bureau  employee,  as  defined  in  these  regulations, 
will  be  furnished  with  a  numbered  official  badge,  which  he  shall  not 
allow  to  leave  his  possession.  This  badge  shall  be  sufficient  iden- 
tification to  entitle  him  to  admittance  at  all  regular  entrances  and  to 
all  parts  of  the  licensed  establishment  and  premises  and  to  any 
place  at  any  time  for  the  purpose  of  making  an  inspection  pursuant 
to  section  1  of  this  regulation. 

REGULATION  7.— FACILITIES  FOR  INSPECTION. 

Section  1.  When  required  by  the  chief  of  bureau  or  the  inspector 
in  charge,  the  following  facilities,  and  such  others  as  may  be  essen- 
tial to  efficient  conduct  of  inspection,  shall  be  furnished  by  each 
licensed  establishment : 

(a)  Satisfactory  pens,  equipment,  and  assistance  for  conducting 
tests  required  in  accordance  with  these  regulations. 

(b)  Suitable  rooms,  compartments,  or  receptacles  in  such  number 
and  places  as  may  be  necessary  for  holding  any  viruses,  serums, 
toxins,  or  analogous  products  for  treatment  or  testing  required  in 
accordance  with  these  regulations.  Such  rooms,  compartments,  or 
receptacles  shall  be  equipped  for  secure  locking  and  shall  be  held 
under  locks  furnished  by  the  department,  and  the  keys  of  such  locks 
shall  not  leave  the  custody  of  bureau  employees. 

(c)  Suitable  containers  satisfactorily  equipped  for  thoroughly 
mixing  batches  of  anti-hog-cholera  serum  and  hog-cholera  virus. 

(d)  Thermometers  which  will  register  temperatures  accurately 
and  satisfactorily  for  use  as  required  by  these  regulations. 

REGULATION  8.— SANITATION. 

Section  1.  Paragraph  1.  Triplicate  copies  of  plans  properly 
drawn  to  scale,  and  of  specifications,  including  plumbing  and  drain- 


8 

age,  for  remodeling  plants  of  licensed  establishments  and  for  new 
structures,  should  be  submitted  to  the  chief  of  bureau  in  advance  oi 
construction. 

Paragraph  2.  Stables  or  other  premises  for  animals  used  in  the 
production  of  testing  of  viruses,  serums,  toxins,  or  analogous  prod- 
ucts shall  be  properly  ventilated  and  lighted,  appropriately  drained, 
and  guttered,  and  kept  in  good  sanitary  condition. 

Paragraph  3.  Animals  infected  with  or  exposed  to  any  infec- 
tious, contagious,  or  communicable  disease  shall  be  properly  segre- 
gated. 

Paragraph  4-  Licensed  establishments  shall  be  so  located  as  to 
avoid  the  spread  of  disease,  and  suitable  arrangements  shall  be 
made  for  the  disposal  of  all  refuse. 

Paragraph  5.  Direct  communication  to  licensed  establishments 
shall  not  be  maintained  from  public  stockyards,  abattoir  pens,  or 
other  places  in  which  animals  are  received  or  held  for  any  purpose. 

Paragraph  6.  All  viruses,  serums,  toxins,  and  analogous  products 
shall  be  prepared,  handled,  and  distributed  with  due  sanitary  pre- 
cautions, and  all  viruses,  serums,  toxins,  or  analogous  products 
shipped  or  delivered  for  shipment  shall  be  securely  packed. 

Section  2.  Paragraph  1.  The  floors,  walls,  ceilings,  partitions, 
posts,  doors,  and  all  other  parts  of  all  structures  at  licensed  establish- 
ments shall  be  of  such  material,  construction,  and  finish  as  can  be 
readily  and  thoroughly  cleaned. 

Paragraph  2.  Separate  rooms  or  compartments  shall  be  provided 
for  preparing,  handling,  and  storing  virulent  or  attenuated  micro- 
organisms or  toxins. 

Paragraph  3.  All  rooms  and  compartments  shall  have  abundant 
light  and  sufficient  ventilation  to  insure  sanitary  and  hygienic  condi- 
tions. 

Section  3.  Paragraph  1.  Each  licensed  establishment  shall  have 
dressing  rooms  and  toilet  rooms  and  urinals  sufficient  in  number, 
ample  in  size,  conveniently  located,  properly  ventilated,  and  meeting 
all  requirements  as  to  sanitary  construction  and  equipment.  These 
rooms,  etc.,  shall  be  separate  from  rooms  and  compartments  in  which 
any  viruses,  serums,  toxins,  or  analogous  products  are  prepared, 
handled,  or  stored. 

Paragraph  2.  Each  licensed  establishment  shall  have  modern  lava- 
tory accommodations,  including  running  hot  and  cold  water,  soap, 
towels,  and  the  like.  These  shall  be  located  at  such  places  in  estab- 
lishments as  may  be  essential  to  assure  cleanliness  of  all  persons 
handling  viruses,  serums,  toxins,  or  analogous  products. 

Section  4.  There  shall  be  an  efficient  drainage  and  plumbing 
system  for  the  establishment  and  premises,  and  all  drains  and  gutters 
shall  be  properly  installed  with  approved  traps  and  vents. 

Section  5.  The  water  supply,  both  hot  and  cold,  shall  be  ample 
and  clean.  Adequate  facilities  shall  be  provided  for  the  distribution 
of  water  in  each  establishment  and  for  the  washing  of  all  equipment, 
containers,  machinery,  instruments,  other  apparatus,  and  animals 
used  in  the  preparation,  handling  or  storing  of  any  viruses,  serums, 
toxins,  or  analogous  products. 

Section  6.  All  equipment,  containers,  instruments,  and  other  ap- 
paratus used  in  the  preparation,  handling,  or  storing  of  any  virus, 
serum,  toxin,  or  analogous  product  shall  be  of  such  material,  con- 


struction,  and  design  as  can  be  readily  and  thoroughly  cleaned  and 
sterilized,  and  such  equipment,  containers,  instruments,  and  other 
apparatus  shall  be  handled  so  as  to  insure  freedom  from  contami- 
nation. Equipment,  containers,  instruments,  and  other  apparatus 
used  for  preparing,  handling,  or  storing  virulent  or  attenuated 
microorganisms  or  toxins  shall  not  be  used  for  handling,  preparing, 
or  storing  other  forms  of  biological  products. 

Section  7.  All  establishment  employees  who  handle  viruses, 
serums,  toxins,  or  analogous  products  shall  keep  their  hands  and 
clothing  clean.  The  hands  of  such  employees  shall  not  come  into 
contact  with  am^  viruses,  serums,  toxins,  or  analogous  products,  or 
with  any  part  of  the  equipment,  containers,  instruments,  or  other 
apparatus,  which  after  sterilization  may  come  into  contact  with  any 
such  products. 

Section  8.  Caps,  gowns,  and  other  outer  clothing  worn  by  persons 
while  handling  any  viruses,  serums,  toxins,  or  analogous  products, 
or  by  those  who  enter  any  room,  compartment,  or  place  where  any 
such  products  are  being  handled,  shall  be  of  clean,  white  material 
whenever  practicable. 

Section  9.  The  outer  premises  of  every  licensed  establishment, 
embracing  clocks,  driveways,  approaches,  yards,  pens,  chutes,  and 
alleys,  shall  be  drained  properly  and  kept  in  a  clean  and  orderly  con- 
dition. The  accumulation,  on  the  premises  of  an  establishment,  of 
any  material  in  which  flies  may  breed  is  forbidden.  No  nuisance 
shall  be  allowed  in  any  licensed  establishment  or  on  its  premises. 

Section  10.  Every  practicable  precaution  shall  be  taken  to  keep 
establishments  free  of  flies,  rats,  mice,  and  other  vermin. 

Section  11.  All  parts  of  the  carcasses  of  animals  producing  vi- 
ruses, all  dead  animals,  all  refuse,  and  all  worthless,  contaminated, 
dangerous,  or  harmful  viruses,  serums,  toxins,  or  analogous  products, 
shall  be  incinerated  or  otherwise  destroyed  by  establishments  in  ac- 
cordance with  methods  approved  by  the  chief  of  bureau. 

Section  12.  All  rooms,  compartments,  and  other  places  used  for 
preparing,  handling,  or  storing  viruses,  serums,  toxins,  or  analogous 
products  shall  be  kept  clean  and  sanitary,  and  all  equipment,  con- 
tainers, instruments  and  other  apparatus  used  in  preparing,  han- 
dling, or  storing  any  such  products  shall  be  thoroughly  cleaned  and 
sterilized  before  use. 

Section  13.  Smoking  or  expectorating  in  any  room,  compartment, 
or  place  in  which  viruses,  serums,  toxins,  or  analogous  products  are 
prepared,  handled,  or  stored  is  prohibited. 

REGULATION  9.— STERILIZATION. 

Section  1.  Paragraph  1.  All  equipment,  containers,  instruments, 
and  other  apparatus,  before  being  used  in  preparing,  handling,  or 
storing  viruses,  serums,  toxins,  or  other  analogous  products,  except 
as  prescribed  in  the  following  paragraph,  shall  be  thoroughly  steri- 
lized by  live  steam  at  a  temperature  of  at  least  120°  C.  for  not  less 
than  one-half  hour,  or  by  dry  heat  at  a  temperature  of  at  least  160° 
C.  for  not  less  than  one  hour.  If  for  any  reason  such  methods  of 
sterilization  are  impracticable,  then  a  process  known  to  be  equally 
efficacious  in  destroying  microorganisms  and  their  spores  may  be 
substituted  after  approval  by  the  chief  of  bureau. 
8177—22 2 


10 

Paragraph  2.  Instruments  used  in  connection  with  the  bleeding  of 
virus  pigs  and  hyperimmune  hogs,  and  other  like  equipment,  of 
establishments  manufacturing  hog-cholera  virus  and  anti-hog- 
cholera  serum,  which  are  found  to  be  damaged  by  exposure  to  the 
degree  of  heat  prescribed  in  the  preceding  paragraph,  after  having 
been  thoroughly  cleaned  may  be  sterilized  by  boiling  for  not  less 
than  15  minutes,  provided  apparatus  satisfactory  to  the  inspector  in 
charge  is  furnished  for  this  purpose. 

Paragraph  3.  Licensed  establishments  shall  furnish  satisfactory 
means  for  insuring  that  autoclaves  and  other  sterilizers  operate 
efficiently  and  as  required  by  this  regulation.  Either  efficient  auto- 
matic temperature-recording  gauges  or  iodid  of  starch,  prepared  as 
approved  by  the  chief  of  bureau  as  a  temperature  indicator,  shall  be 
used  in  the  operation  of  autoclaves  and  other  steam  sterilizers.  Such 
gauges  likewise  shall  be  attached  to  dry-heat  sterilizers  unless  they 
can  be  and  are  effectively  operated  under  the  direct  supervision  of 
a  bureau  employee  while  he  is  engaged  on  other  inspection  work 
requiring  his  attention.  Charts  used  on  these  gauges  shall  be  made 
available  at  all  times  for  examination  by  bureau  employees. 

REGULATION   10.— STORAGE. 

Section  1.  Viruses,  serums,  toxins,  and  analogous  products  which 
may  be  injuriously  affected  by  exposure  to  light  or  to  high  temper- 
ature shall  be  stored  in  a  dark,  cold  chamber  or  refrigerator  at  a 
temperature  of  not  to  exceed  55°  F.  All  dealers  in  the  District  of 
Columbia  or  any  Territory  or  in  any  place  under  the  jurisdiction  of 
the  United  States  shall  keep  such  products  protected  from  light 
and  under  refrigeration  until  sold  or  otherwise  disposed  of. 

REGULATION   u.— RECORDS. 

Section  1.  Paragraph  1.  Permanent  detailed  records  of  the 
sources  of  the  preparation,  of  tests  for  purity  and  potency,  and  of 
methods  of  preservation  of  each  batch  of  virus,  serum,  toxin,  and 
analogous  products  shall  be  kept  by  each  licensed  establishment  and 
by  each  manufacturer  producing  such  products  for  importation  into 
the  United  States. 

Paragraph  2.  Permanent  detailed  records  in  a  form  satisfactory 
to  the  chief  of  the  bureau  shall  be  maintained  by  each  licensed  estab- 
lishment and  by  each  importer,  showing  the  saie,  shipment,  or  other 
disposition  of  the  viruses,  serums,  toxins,  and  analogous  products 
handled. 

REGULATION   12.— LABELS. 

Section  1.  Paragraph  1.  Each  immediate  or  true  container  of 
viruses,  serums,  toxins,  or  analogous  products,  prepared  for  sale, 
barter,  exchange,  or  shipment  by  any  licensed  establishment  or  im- 
porter into  the  United  States,  shall  bear  a  trade  label  as  hereinafter 
described. 

Paragraph  0.  No  container  of  virus,  serum,  toxin,  or  analogous 
product  shall  bear  a  trade  label  unless  and  until  the  product  contained 
therein  shall  have  been  prepared  in  compliance  with  these  regulations 
and  not  found  to  be  worthless,  contaminated,  dangerous,  or  harmful, 


11 

except  that  containers  of  antihog-cholera  serum  and  hog-cholera 
virus  prepared  as  aforesaid  may  be  labeled  and  marked  before  the 
products  are  released  for  marketing,  provided  such  labeling  and 
marking  are  done  under  the  direct  supervision  of  a  bureau  employee 
and  the  products  immediately  thereafter  placed  under  bureau  lock, 
where  they  will  be  held  until  released  for  marketing.  No  person 
shall  have  access  to  the  compartment  in  which  such  labeled  or  marked 
products  are  held  under  lock  except  in  the  immediate  presence  of  a 
bureau  employee. 

Paragraph  3.  Xo  person  shall  apply  or  affix,  or  cause  to  be  applied 
or  affixed,  any  trade  label,  stamp,  or  mark  to  any  container  of  hog- 
cholera  virus  or  antihog- cholera  serum,  prepared  or  received  in  a 
licensed  establishment  except  in  compliance  with  these  regulations. 
Suitable  tags  or  labels  of  a  distinct  design  should  be  used  for  identi- 
fying all  biologies  while  in  course  of  preparation. 

Section  2.  Paragraph  1.  Trade  labels  shall  bear  the  true  name  of 
the  product  contained  in  the  package,  and  this  name  shall  be  identical 
with  that  given  in  the  license  under  which  the  product  is  prepared. 
The  name  shall  also  be  so  lettered  and  placed  as  to  give  equal  promi- 
nence to  each  word  composing  it.  Such  labels  shall  also  bear  the 
oame  and  address  of  the  manufacturer  and  the  license  or  permit 
number  assigned  by  the  department.  The  license  number  and 
permit  shall  be  shown  in  either  of  the  following  forms,  respec- 
tively :  ;;  U.  S.  Veterinary  License  Xo. ,"  or  "  U.  S.  Vet.  License 

Xo.  - — ."  and  ;'U.  S.  Veterinary  Permit  Xo. ,"  or  "U.  S.  Vet. 

Permit  Xo. .''  These  labels  shall  bear  all  other  information  re- 
quired by  the  chief  of  bureau,  and  may  also  bear  any  other  statement 
not  false  or  misleading,  and  which  has  been  approved  by  the  bureau. 

Paragraph  2.  Each  trade  label  shall  bear  a  serial  number,  affixed 
by  the  manufacturer,  by  which  the  product  can  be  identified  with  the 
records  of  preparation. 

Paragraph  3.  Each  trade  label  shall  bear  a  return  date  affixed  be- 
fore the  product  is  removed  from  the  establishments.  The  date 
shown  shall  be  a  date  after  which  the  manufacturer  does  not  guar- 
antee the  product  to  be  of  full  strength  or  potency. 

Paragraph  J±.  All  trade  labels  affixed  to  or  used  in  connection  with 
each  immediate  or  true  container  shall  bear  a  dosage  table  and  full 
instructions  governing  the  use  of  the  product. 

Paragraph  5.  Trade  labels  affixed  to  the  immediate  or  true  con- 
tainers of  viruses  and  products  prepared  from  attenuated  organisms 
shall  bear,  in  addition  to  the  statements  required  by  the  preceding 
paragraphs  of  this  section,  the  following,  prominently  placed  and 
lettered:  "  Catjitton — Burn  this  Container  and  all  Unused  Con- 
tents.'' 

Paragraph  6.  When  any  virus,  serum,  toxin,  or  analogous  product 
is  prepared  by  a  licensed  establishment,  or  imported  for  a  person 
other  than  the  one  to  whom  a  license  or  permit  has  been  issued,  and 
the  name  and  address  of  the  distributor,  as  well  as  that  of  the  manu- 
facturer, is  to  appear  on  the  trade  labels  of  the  containers  thereof, 
a  statement  shall  be  made  on  the  labels  indicating  that  the  virus, 
serum,  toxin,  or  analogous  product  is  distributed  by  such  person. 
The  name  and  address  of  this  person  shall  not  appear  in  any  form 


12 

or  manner  indicating  that  the  distributor  is  the  producer  of  the 
product,  and  operating  under  the  license  as  shown  on  the  label. 
The  terms  "  Distributor,"  "  Distributors."  "  Distributed  by,"  or 
equivalent  terms  may  be  used  if  prominently  placed  and  lettered,  in 
connection  with  the  name  and  address  of  the  distributing  person, 
provided  the  same  are  not  used  so  as  to  be  either  false  or  misleading. 
Reference  to  the  distributing  person  shall  be  made  by  name  and 
address  only. 

Paragraph  7.  Copies  of  all  trade  labels  before  use  shall  be  sub- 
mitted to  the  bureau  for  examination  and  approval.  These  labels 
shall  be  submitted  in  triplicate,  quadruplicate,  or  quintruplicate,  as 
may  be  indicated.  Triplicate  copies  of  new  trade  labels  in  the  form 
of  sketches,  proofs,  or  photographic  copies  should  be  submitted, 
through  the  inspector  in  charge,  to  the  bureau  for  approval. 

REGULATION   13.— COLLECTING  SAMPLES. 

Section  1.  Paragraph  1.  Samples  of  viruses,  serums,  toxins,  and 
analogous  products  shall  be  collected  by  authorized  officers,  agents,  or 
employees  of  the  department. 

Paragraph  2.  Samples  may  be  purchased  in  the  open  market,  and 
the  marks,  brands,  or  tags  upon  the  package  or  wrapper  thereof  shall 
be  noted.  The  collector  shall  note  the  names  of  the  vendor  and 
agent  of  the  vendor  who  made  the  sale,  together  with  the  date  of 
purchase.     The  collector  shall  purchase  representative  samples. 

Paragraph  3.  All  samples  or  parts  of  samples  shall  be  sealed  by 
the  collector  and  marked  with  identifying  marks. 

REGULATION   14.— PRODUCTION,  TESTING,  ETC. 

Section  1.  Except  as  otherwise  provided  in  these  regulations,  all 
viruses,  serums,  toxins,  and  analogous  products  shall  be  prepared, 
handled,  stored,  marked,  treated,  and  tested  by  licensed  establish- 
ments in  accordance  with  methods  prescribed  by  the  Chief  of  the 
Bureau  of  Animal  Industry. 

REGULATION   15.— RETESTING. 

Section  1.  Viruses,  serums,  toxins,  and  analogous  products,  the 
containers  of  which  bear  United  States  veterinary  license  numbers  or 
United  States  veterinary  permit  numbers,  or  any  other  mark  required 
by  these  regulations,  shall  be  subject  to  inspection  at  any  time  or 
place.  If,  as  a  result  of  such  inspection,  it  appears  that  any  such 
product,  even  though  prepared  in  a  licensed  establishment  or  im- 
ported under  permit  issued  by  the  Secretary,  is  worthless,  con- 
taminated, dangerous,  or  harmful,  the  Secretary  shall  give  notice 
thereof  to  the  manufacturer  or  importer  and  to  any  jobbers,  dealers, 
or  other  persons  known  to  have  any  of  such  product  in  their  posses- 
sion. Unless  and  until  the  Secretary  shall  otherwise  direct,  no  person 
so  notified  shall  thereafter  sell,  barter,  or  exchange  in  any  place  under 
the  jurisdiction  of  the  United  States  nor  shall  thereafter  ship  or 
deliver  for  shipment  from  any  State.  Territorv.  or  the  District  of 
Columbia  to  any  other  State,  Territory,  or  the  District  of  Columbia, 
any  of  such  product. 


13 

REGULATION   16.— REPORTS. 

Section  1.  Paragraph  1.  Reports  of  the  work  of  inspection  carried 
on  in  every  licensed  establishment  shall  be  forwarded  to  the  bureau 
by  the  inspector  in  charge  in  such  form  and  manner  as  may  be  speci- 
fied by  the  chief  of  bureau. 

Paragraph  2.  Each  licensed  establishment  shall  furnish  to  bureau 
employees  accurate  information  as  to  all  matters  needed  by  them 
for  making  their  reports  pursuant  to  paragraph  1  of  this  section. 
and  shall  submit  such  reports  as  may  be  required  by  the  chief  of 
bureau. 

REGULATION   17.— ANIMALS. 

Section  1.  Paragraph  1.  Licensed  establishments  which  procure 
animals  from  public  stockyards,  abattoir  pens,  or  similar  places 
shall  afford  opportunity  for  all  hogs,  cattle,  sheep,  and  goats  ad- 
mitted to  the  premises  of  such  establishments  to  range  in  contact 
with  other  animals  as  prescribed  in  section  3  of  this  regulation. 

Paragraph  2.  Cattle,  sheep,  and  goats  from  whatever  source,  ex- 
cept "  contact  calves  "  and  those  admitted  by  certificate  as  permitted 
by  section  5  of  this  regulation  upon  admission  to  the  premises  of 
licensed  establishments,  shall  be  afforded  opportunity  to  range  in 
contact  with  other  animals  as  prescribed  in  section  3  hereof. 

Section  2.  Paragraph  1.  Licensed  establishments  shall  provide 
suitable  pens  to  be  known  as  "  receiving  pens  "  through  which  all 
hogs,  cattle,  sheep,  and  goats  shall  pass  in  accordance  with  the 
provisions  o'f  this  regulation  before  they  shall  be  admitted  to  any 
other  part  of  the  premises. 

Paragraph  2.  Licensed  establishments  shall  provide  healthy  calves 
in  thrifty  condition  and  ranging  from  3  to  12  months  of  age  for 
use  as  contact  animals  in  receiving  pens.  They  shall  be  referred 
to  as  "contact  calves." 

Paragraph  3.  Each  contact  calf  shall  have  the  left  ear  thereof 
pierced  with  a  hole  not  less  than  three -fourths  inch  in  diameter 
and  to  the  right  ear  of  each  animal  shall  be  attached  a  serially  num- 
bered metal  tag. 

Section  3.  Paragraph  1.  All  animals  covered  by  section  1  of  this 
regulation,  except  hogs,  shall  be  held  in  receiving  pens  for  at  least 
48  hours  as  prescribed  in  paragraph  2  of  this  section,  and  not  le>s 
than  two  contact  calves  shall  be  used  for  each  lot  of  20  animals 
or  less  in  the  same  pen. 

Paragraph  2.  All  hogs  which  are  admitted  to  the  premises  of 
licensed  establishments  under  the  provisions  of  section  1,  para- 
graph 1.  of  this  regulation,  shall  be  held  in  receiving  pens  for  at 
least  21  hours  after  admission  to  the  premises,  with  the  exception 
of  pigs  which  are  used  in  testing  the  potency  and  purity  of  anti- 
hog-cnolera  serum  and  the  virulence  of  hog-cholera  virus,  in  which 
case  six  hours  will  be  sufficient :  and  during  this  time  all  these  ani- 
mals shall  be  allowed  free  range  and  contact  with  not  less  than 
two  contact  calves  for  each  lot  of  200  hogs  or  less  in  the  receiving 
pens.  Hogs  immune  to  hog  cholera  may  be  removed  from  the  re- 
ceiving pens  for  hyperimmunization  at  any  time  while  being  held 
as  aforesaid,  provided  they  are  returned  to  the  receiving  pens 
immediately  after  this   operation. 


14 

Section  4.  Paragraph  1.  All  surviving  contact  calves  shall  be 
held  in  the  receiving  pens  of  licensed  establishments  for  at  least 
one  month  from  date  of  admission  to  receiving  pens  as  contact 
calves. 

Paragraph  2.  The  removal  of  contact  calves  from  receiving  pens 
shall  be  so  arranged  that  one  animal  of  each  group  of  two  will 
be  replaced  at  the  expiration  of  one  month  and  the  other  at  the 
expiration  of  two  months. 

Paragraph  3.  Eemoval  of  contact  calves  from  receiving  pens 
shall  be  accomplished  so  that  the  animal  last  furnished  for  the  pur- 
pose may  be  used  for  the  maximum  time  permitted  by  the  preced- 
ing paragraphs  of  this  section.  No  contact  calf  shall  be  used  as 
such  more  than  once,  but  may  be  used  for  testing  simultaneous 
virus  after  release  as  a  contact  animal. 

Paragraph  4-  Contact  calves  shall  be  carefully  examined  by  a 
veterinary  inspector  as  frequently  as  may  be  necessary  to  detect  evi- 
dence of  disease. 

Section  5.  Establishments,  licensed  to  prepare  anti-hog-cholera 
serum  or  hog-cholera  virus,  which  procure  no  animals  from  public 
stockyards,  abattoir  pens,  or  similar  places  shall  furnish  a  properly 
executed  certificate  in  the  following  form  covering  each  lot  or  ship- 
ment of  animals  offered  for  admission  to  the  premises  thereof,  or  in 
lieu  of  this  said  animals  shall  be  held  in  contact  with  calves  as  pre- 
scribed in  section  3  of  this  regulation.  These  certificates  shall  be 
signed  by  an  authorized  representative  of  the  licensed  establishment. 


19 


This  is  to  certify  that ^cm?  which  are  offered  for 

admission  to  the  establishment  of  the 

Co.  are  from  the  farm  or  premises  of .  in  the  State  of 

,  county  of ,  township  of , 

and  to  the  best  of  our  knowledge  and  belief  were  on  said  farm  or  premises  at 
least  21  days  prior  to  this  date,  and  were  not  exposed  to  any  infectious,  con- 
tagious, or  communicable  disease,  and  no  new  stock  was  brought  on  to  the 
said  farm  or  premises  during  that  time.  The  said  animals  have  not  been  in 
or  transported  through  any  public  stockyards,  abattoir  pens,  or  similar  places, 
nor  have  they  been  exposed  to  any  infectious,  contagious,  or  communicable 
disease  since  their  removal  from  said  farm  or  premises. 

(Signed)  Co.. 

Per 

Section  6.  Paragraph  1.  All  animals  presented  for  admission  tc 
the  premises  of  establishments  licensed  to  prepare  anti-hog-cholera 
serum  or  hog-cholera  virus  shall  be  examined  by  a  veterinary  in- 
spector as  soon  as  practicable  after  they  are  received  and  before 
their  removal  from  the  receiving  pens  in  order  to  determine  their 
physical  condition.  Xo  animal  shall  be  removed  from  receiving  pens 
without  examination  by  and  the  permission  of  a  veterinary  inspector. 

Paragraph  2.  After  examination,  if  the  animals  are  permitted  to 
remain  upon  the  premises  and  to  enter  the  holding  pens  of  the 
establishment,  they  shall  be  given  serially  numbered  metal  tags, 
either  prior  to  or  at  the  time  of  inoculation  or  hyperimmunization. 

Paragraph  3.  All  tags  used  for  the  identification  of  animals  shall 
be  attached  to  the  ears  of  the  animals  in  a  manner  satisfactory  to 
the  inspector  in  charge.  The  tags  so  attached  shall  be  the  means 
of  assisting  in  identifying  the  animals  so  long  as  they  remain  on  the 
premises. 


15 

Paragraph  4.  All  tags  which  are  used  to  identify  animals  shall  be 
furnished  and  attached  by  the  licensed  establishment  except  that, 
when  so  ordered  by  the  chief  of  bureau,  only  tags  furnished  by  the 
Bureau  of  Animal  Industry  shall  be  used  for  tagging  pigs  and 
calves  used  for  testing  anti-hog-cholera  serum  and  hog-cholera  virus, 
and  when  said  tags  are  not  in  actual  use  they  shall  be  held  at  all 
times  in  the  custody  of  a  bureau  employee. 

Paragraph  5.  The  left  ear  of  each  animal  used  in  testing  the 
purity  and  potency  of  viruses,  serums,  toxins,  and  analogous  products 
shall  be  pierced,  if  of  sufficient  size  to  admit  of  the  procedure,  when 
the  test  is  started,  with  a  hole  of  not  less  than  three-fourths  inch  in 
diameter,  except  when  pigs  are  used  in  testing  hog-cholera  virus  for 
purity  as  prescribed  in  paragraphs  8,  9,  and  10,  section  4,  Regula- 
tion 18  of  this  order,  their  right  ears  shall  be  pierced  as  aforesaid. 
Animals  bearing  marks  of  the  above-described  character  shall  not 
be  presented  by  licensed  establishments  for  use  in  testing  the  purity 
and  potency  of  any  virus,  serum,  toxin,  or  analogous  product,  except 
that  "  contact  calves  "  after  release  as  prescribed  in  section  4  of  this 
regulation  and  serum-treated  pigs  in  anti-hog-cholera  serum  tests 
after  release  as  prescribed  in  paragraphs  6  and  7,  section  4,  Regu- 
lation 19  of  this  order  may  be  used  once  for  testing  hog-cholera 
virus  for  purity,  provided  they  are  healthy  and  their  right  ears  then 
are  pierced  as  aforesaid.  Furthermore,  animals  with  either  ear  re- 
moved or  mutilated  so  as  to  prevent  the  detection  of  these  identifying 
marks  shall  not  be  used  in  any  test,  if  the  missing  or  mutilated  ears 
are  needed  to  determine  the  suitability  of  the  animals  for  test  pur- 
poses as  described  herein.  The  piercing  of  the  ears  of  animals  must 
be  accomplished  in  the  manner  prescribed  in  this  order  or  in  such 
manner  as  may  be  prescribed  by  the  chief  of  bureau. 

Section  7.  Animals  used  in  the  production  or  testing  of  viruses, 
serums,  toxins,  or  analogous  products  shall  not  be  treated  with  bio- 
logical products  other  than  those  which  are  incidental  to  the  prepara- 
tion and  testing  of  the  products  prepared  from  or  tested  upon  said 
animals,  except  with  the  approval  of  and  in  such  manner  as  may  be 
prescribed  by  the  chief  of  bureau. 

Section  8.  Paragraph  1.  If  for  any  reason  hyperimmune  hogs  are 
practically  the  only  animals  held  upon  the  premises  of  a  licensed 
establishment,  they  shall  be  caused  to  range  in  contact  with  calves  in 
the  manner  prescribed  in  section  3  of  this  regulation  for  a  period  of 
at  least  10  days  prior  to  their  being  subjected  to  carotid  or  final 
bleeding. 

Paragraph  2.  All  animals  with  which  hyperimmune  hogs  have 
been  held  in  contact  as  prescribed  in  this  section  shall  be  held  on  the 
premises  of  the  licensed  establishment  and  under  the  observation  of 
a  bureau  employee  for  at  least  two  weeks  after  the  hyperimmune 
hogs  have  been  destroyed. 

Paragraph  3.  If  at  any  time  the  bureau  requires  that  hyperimmune 
hogs  be  subjected  to  the  tail-bleeding  process  only,  those  surviving 
shall  be  held  under  the  supervision  of  a  bureau  employee  for  at  least 
two  weeks  after  the  last  tail  bleeding  has  been  collected,  but  this 
shall  not  operate  to  prevent  post-mortem  examinations  of  the 
animals  from  being  made  as  required  by  these  regulations. 

Section  9.  Paragraph  1.  Hogs,  cattle,  sheep,  or  goats  shall  not 
be  removed  from  the  premises  of  establishments  licensed  to  produce 


16 

anti-hog-cholera  serum  or  hog-cholera  virus  without  the  written 
permission  of  the  inspector  in  charge. 

Paragraph  2.  Permission  to  remove  animals  from  the  premises 
of  establishments  as  described  in  the  preceding  paragraph  will  be 
given  by  the  inspector  in  charge  under  the  following  conditions,  pro- 
vided the  removal  of  said  animals  is  accomplished  in  such  a  manner 
as  will  preclude  the  dissemination  of  disease. 

(a)  Animals  named  in  paragraph  1  of  this  section  that  are  not  in 
a  healthy  condition  as  determined  by  a  veterinary  inspector,  except 
when  affected  with  a  communicable  disease  other  than  hog  cholera 
and  tuberculosis,  may  be  removed  from  establishments  for  immedi- 
ate slaughter  in  a  federally  inspected  abattoir  if  they  are  transported 
thereto  by  truck,  wagon,  or  similar  means  and  not  by  rail,  provided 
they  are  properly  marked  for  identification  and  the  inspector  in 
charge  of  meat  inspection  is  given  due  notice  thereof  in  advance. 

If  a  federally  inspected  abattoir  is  not  accessible  as  aforesaid, 
the  slaughter  of  said  animals  may  be  conducted  in  any  convenient 
unofficial  abattoir  provided  the  licensed  establishment  signifies  its 
willingness  in  writing  to  dispose  of  the  carcasses  under  the  pro- 
visions of  the  meat-inspection  regulations  and  as  directed  by  a  veteri- 
nary inspector  after  a  post-mortem  examination  has  been  conducted 
by  him. 

(h)  Hogs  that  are  in  a  healthy  condition  as  determined  by  a 
veterinary  inspector  may  be  removed  from  establishments  provided 
they  are  or  have  been  treated  or  vaccinated  and  disinfected  as  pre- 
scribed in  paragraphs  3  and  4  of  this  section.  Such  hogs  need  not 
be  vaccinated  or  disinfected  by  the  establishment  when  removed  for 
immediate  slaughter  in  a  federally  inspected  abattoir  or  to  a  public 
stockyards  from  which  no  hogs  are  permitted  to  be  removed  for  pur- 
poses other  than  immediate  slaughter  without  vaccination  and  dis- 
infection under  bureau  supervision.  When  hogs  are  removed  to 
abattoirs  or  public  stockyards  without  vaccination  and  disinfection 
as  aforesaid,  the  licensed  establishment  shall  furnish  the  bureau  with 
a  certificate  from  the  consignee  of  the  animals  at  the  abattoir  or 
public  stock}^ards  showing  their  slaughter  therein  or  receipt  thereby, 
respectively.  If  the  animals  are  not  disinfected,  they  shall  not  be 
transported  by  rail  or  driven  over  public  highways  which  are  not 
traversed  by  animals  from  stockyards  or  similar  places. 

(c)  Calves  that  are  in  a  healthy  condition  as  determined  by  a 
veterinary  inspector  may  be  removed  from  establishments  after 
disinfection  as  described  in  subdivision  (#),  paragraph  4  of  this  sec- 
tion, except  that  when  removed  to  an  abattoir  without  passing 
through  stockyards,  or  over  public  highways  which  are  not  traversed 
by  animals  from  public  stockyards  or  similar  places,  the  animals 
need  not  be  so  disinfected  provided  the  licensed  establishment  fur- 
nishes the  bureau  with  a  certificate  from  the  consignee  of  the  animals 
at  the  abattoir  showing  their  slaughter  therein. 

(d)  Pigs  which  survive  inoculation  and  exposure  to  hog  cholera 
for  the  production  of  hog-cholera  virus,  surviving  pigs  which  have 
been  used  for  testing  hog-cholera  virus,  and  surviving  control  pigs 
in  tests  of  anti-hog-cholera  serum  may  be  removed  from  establish- 
ments not  earlier  than  15  days  subsequent  to  the  time  of  inoculation 
and  exposure  as  aforesaid,  provided  they  are  healthy,  as  determined 


17 

by  a  veterinary  inspector,  and  are  first  given  the  serum- alone  treat- 
ment as  described  in  subdivision  (a),  paragraph  3,  and  are  dis- 
infected as  set  forth  in  subdivision  (&),  paragraph  4  of  this  section, 
except  that  when  removed  for  immediate  slaughter  or  to  public 
stockyards  as  defined  in  subdivision  (b)  of  this  paragraph,  said 
animals  need  not  be  so  treated  or  disinfected. 

(e)  Hyperimmune  hogs,  or  those  treated  in  a  similar  manner,  and 
pigs  which  have  been  used  for  testing  anti-hog-cholera  serum  may 
be  removed  from  establishments  not  earlier  than  21  days  subsequent 
to  the  time  of  hyperimmunization  or  inoculation,  provided  they  are 
healthy,  as  determined  by  a  veterinary  inspector,  and  are  disinfected 
as  prescribed  in  subdivision  (&),  of  paragraph  4  of  this  section,  except 
that  when  removed  for  immediate  slaughter  or  to  public  stockyards 
as  set  forth  in  subdivision  (b)  of  this  paragraph,  said  animals  need 
not  be  so  disinfected. 

Paragraph  3.  All  hogs  which  require  treatment  or  vaccination  as 
defined  in  the  preceding  paragraph  of  this  section  shall  be  treated 
as  follows: 

(a)  Serum-alone  method.  The  serum  used  shall  have  been  pre- 
pared and  released  for  marketing  at  an  establishment  holding  a 
license  from  the  Secretary  of  Agriculture  and  the  dose  employed 
shall  conform  to  that  required  in  Regulation  19  of  this  order. 

(b)  Simultaneous-inoculation  method. — The  serum  and  virus  used 
shall  have  been  prepared  at  an  establishment  holding  a  license  from 
the  Secretary  of  Agriculture  and  the  doses  shall  be  not  less  than 
those  required  in  Regulations  18  and  19  of  this  order.  After  receiv- 
ing this  treatment  they  shall  be  held  under  the  supervision  of  a 
bureau  employee  for  a  period  of  at  least  21  days,  except  when  treated 
with  virus  and  serum  released  for  marketing. 

Paragraph  4-  All  animals  which  require  disinfection  as  defined  in 
paragraph  2  of  this  section  shall  be  treated  as  follows : 

(a)  The  feet,  legs,  and  soiled  portions  of  the  body  of  calves  to  be 
removed  from  establishments  shall  be  cleaned  and  disinfected  with  a 
2  per  cent  aqueous  solution  of  cresol  compound,  U.  S.  P.,  or  permitted 
substitute  therefor,  and  these  animals  shall  then  be  held  in  non- 
infectious pens  on  the  premises  of  the  establishment  until  they  are 
dry  before  being  loaded  for  transportation. 

(b)  Hogs  shall  be  disinfected  in  a  2  per  cent  aqueous  solution  of 
cresol  compound,  U.  S.  P.,  or  a  permitted  substitute  therefor,  and  be 
held  in  noninfectious  pens  on  the  premises  for  at  least  three  hours 
before  being  loaded  for  transportation,  except  that  hogs  transported 
in  trucks,  wagons,  or  by  similar  means  may  be  removed  as  soon  after 
disinfection  as  they  are  observed  by  a  veterinary  inspector  to  be 
thoroughly  dry,  if  said  animals  are  not  made  wet  before  their 
removal  from  the  premises. 

Section  10.  Except  as  otherwise  provided  in  these  regulations, 
all  animals  used  by  licensed  establishments  in  the  preparation  or 
testing  of  veterinary  biologies  shall  meet  such  requirements  as  may 
be  prescribed  by  the  chief  of  bureau  and  deemed  by  him  necessary 
to  prevent  the  preparation  and  sale  of  any  worthless,  contaminated, 
dangerous,  or  harmful  viruses,  serums,  toxins,  or  analogous  prod- 
ucts. 

8177—22 3 


18 

Section  11.  Each  licensed  establishment  shall  adopt  such  meas- 
ures as  the  chief  of  bureau  shall  from  time  to  time  prescribe  for 
carrying  out  the  provisions  of  this  regulation. 

REGULATION   18.— HOG-CHOLERA  VIRUS 

Section  1.  Paragraph  1.  All  operations  incident  to  the  produc- 
tion of  hog-cholera  virus  shall  be  conducted  under  the  supervision 
of  a  bureau  emploj^ee.  Each  licensed  establishment  shall  notify  the 
inspector  in  charge  or  his  assistant  a  reasonable  time  in  advance 
whenever  any  operations  are  to  be  conducted. 

Paragraph  2.  Pigs  which  are  used  in  the  production  of  hog- 
cholera  virus  shall  be  healthy,  and  the  temperature  of  each  animal 
shall  be  accurately  taken  and  permanently  recorded  by  the  establish- 
ment immediately  before  inoculation  when  in  the  opinion  of  the 
inspector  in  charge  this  is  necessary  to  determine  the  health  of  the 
animals.  Each  animal  shall  be  subjected  to  a  careful  examination 
by  a  veterinary  inspector  immediately  prior  to  inoculation. 

Paragraph  3.  Temperatures  of  all  pigs  used  to  produce  hog- 
cholera  virus  shall  be  correctly  taken  and  recorded  by  licensed  estab- 
lishments each  day  subsequent  to  the  fourth  day  after  inoculation 
and  at  such  other  times  as  the  inspector  in  charge  may  deem  neces- 
sary. The  temperature  of  each  pig  invariably  shall  be  taken  and 
recorded  on  each  day  the  animal  is  slow  or  visibly  sick. 

Paragraph  4.  Pigs  from  which  virus  for  the  inoculation  of  other 
pigs  in  the  production  of  virus  is  derived  shall  weigh  not  more 
than  100  pounds  each.  Hog-cholera  virus  of  licensed  establishments 
shall  not  be  used  for  inoculating  pigs  for  the  production  of  virus 
later  than  15  days  after  the  date  of  its  collection,  but  such  virus 
which  is  not  more  than  60  days  old  and  which  has  been  held  con- 
tinuous^ by  licensed  establishments  at  a  temperature  of  not  more 
than  55°  F.  (12.8°  C.)  may  be  made  suitable  for  said  inoculation 
purposes  by  passing  it  through  pigs  of  the  same  weights  and  in  the 
same  manner  as  prescribed  in  paragraph  3,  section  1,  Regulation  21 
of  these  regulations.  The  virus  derived  from  these  pigs  may  be 
used  for  hyperimmunization  if  the  animals  react  as  prescribed  in  the 
following  paragraph  of  this  section. 

Paragraph  5.  Pigs  from  which  blood  is  to  be  collected  for  the  pro- 
duction of  hog-cholera  virus  shall  be  killed  only  after  permission  has 
been  given  by  a  veterinary  inspector  who  has  observed  them  to  mani- 
fest well-marked  and  increasingly  grave  symptoms  of  hog  cholera 
only,  attended  with  progressively  abnormal  temperatures  com- 
mon to  the  acute  type  of  this  disease.  These  pigs  shall  be  free  from 
other  communicable  diseases,  except  as  provided  in  paragraph  9  of 
this  section. 

Paragraph  6.  All  pigs  from  which  hog-cholera  virus  is  derived 
shall  be  subjected  to  a  post-mortem  examination  by  a  veterinary  in- 
spector, except  that  trained  lay  inspectors  may  conduct  these  exami- 
nations on  hyperimmunizing  virus  pigs  subject  to  review  by  a  veteri- 
nary inspector,  who  should  make  all  decisions  on  questionable 
matters. 

Paragraph  7.  Hog-cholera  virus  derived  from  pigs  which  become 
visibly  sick  within  three  days  after  the  time  they  are  admitted  to  the 


i 


19 

premises  of  licensed  establishments  shall  be  destroyed  as  provided  in 
section  11,  Regulation  8,  under  the  supervision  of  a  bureau  employee. 

Paragraph  8.  Hog-cholera  virus  derived  from  pigs  which  upon 
post-mortem  examination  do  not  show  lesions  sufficient  for  a  veteri- 
nary inspector  to  make  a  positive  diagnosis  of  hog  cholera,  when  con- 
sidered with  the  ante-mortem  behavior  of  the  animal,  or  which  are 
found  to  be  so  affected  with  any  infectious,  contagious,  or  communi- 
cable disease,  or  in  such  condition  as  to  render  the  virus  contaminated, 
shall  be  destroyed  as  provided  in  section  11,  Regulation  8,  under  the 
supervision  of  a  bureau  employee.  Virus  passed  by  bureau  em- 
ployees may  be  destroyed  as  aforesaid  at  the  discretion  of  the  estab- 
lishment. 

Paragraph  9.  Hog-cholera  virus  derived  from  pigs  which  are 
found  to  be  affected  with  tuberculosis  shall  be  destroyed  as  provided 
in  section  11,  Regulation  8,  under  the  supervision  of  a  bureau  em- 
ployee, unless  the  lesions  are  slight  or  are  localized,  and  are  calcified 
or  encapsulated.  Hog-cholera  virus  derived  from  pigs  affected  as 
described  shall  not  be  marketed. 

Paragraph  10.  All  records  shall  indicate  clearly  the  particular  ani- 
mal, or  group  of  animals,  from  which  each  batch  of  hog-cholera 
virus  is  derived.  The  amount  collected  and  the  total  amount  after 
phenolization  should  be  separately  recorded. 

Paragraph  11.  Hog-cholera  virus  shall  not  be  removed  from  the 
premises  of  a  licensed  establishment  unless  the  virus  has  been  pre- 
pared in  accordance  with  the  provisions  of  these  regulations. 

Paragraph  12.  No  immediate  or  true  container  of  hog-cholera  virus 
shall  be  filled  in  whole  or  in  part,  and  no  trade  label  shall  be  affixed 
to  such  container  except  under  the  supervision  of  a  bureau  employee. 

Paragraph  13.  The  following  special  facilities,  and  such  others  as 
may  be  required  by  the  chief  of  bureau,  shall  be  provided  by  each 
establishment  licensed  to  prepare  hog-cholera  virus  : 

{a)   Separate  operating  rooms. 

(h)  A  separate  room  in  which  the  animals  shall  be  washed,  cleaned, 
and  otherwise  prepared  before  being  taken  into  the  operating  room. 

(c)  A  separate  room  for  conducting  autopsies. 

(d)  A  separate  room  for  the  preparation  and  mixing  of  virus. 

(e)  A  separate  room  for  washing  and  sterilizing  equipment. 

(/)  Clean  cloths  which  shall  be  kept  damp  when  in  use,  to  be  used 
for  covering  pigs  during  all  operations  incident  to  the  collection  of 
hog-cholera  virus. 

(g)  All  outside  doors,  openings,  and  windows  shall  be  equipped 
with  dust  screens. 

Paragraph  llf.  All  persons  immediately  before  entering  the  oper- 
ating or  laboratory  rooms  of  an  establishment  licensed  to  prepare 
hog-cholera  virus  when  these  rooms  are  in  use,  shall  change  their 
outer  clothing  or  cover  it  by  the  use  of  clean  gowns  or  other  satis- 
factory garments. 

Section  2.  Paragraph  1.  For  use  in  the  production  of  hyperim- 
munizing  virus,  licensed  establishments  shall  inoculate  young  pigs 
weighing  not  more  than  145  pounds  each  with  at  least  2  cubic  centi- 
meters of  a  virulent  strain  of  hog-cholera  virus,  except  that  when 
sickness  from  pen  infection  is  manifested  by  the  animals  after  the 
fourth  day  subsequent  to  admission  to  the  premises,  they  need  not 
be  so  inoculated. 


20 

Paragraph  2.  Hyperimmunizing  virus  shall  be  collected  only  from 
pigs  which  are  observed  by  a  veterinary  inspector  to  be  visibly  sick 
with  hog  cholera  and  which  manifest  well-marked  and  increasingly 
grave  symptoms  thereof  attended  with  progressively  abnormal  tem- 
peratures common  to  the  acute  type  of  this  disease. 

Section  3.  Paragraph  1.  For  use  in  the  production  of  simultane- 
ous virus,  licensed  establishments  shall  inoculate  young  pigs,  weigh- 
ing not  less  than  40  pounds  nor  more  than  100  pounds  each,  with  at 
least  2  cubic  centimeters  of  a  virulent  strain  of  hog-cholera  virus. 

Paragraph  2.  Simultaneous  virus  shall  not  be  collected  from  pigs 
which  become  visibly  sick  on  or  before  the  third  day,  or  subsequent 
to  the  sixth  day  after  the  time  of  inoculation.  The  physical  condi- 
tion of  pigs  from  which  simultaneous  virus  is  collected  shall  be 
recorded  daily  on  and  after  the  third  day  subsequent  to  inoculation. 

Paragraph  3.  Simultaneous  virus  and  hog-cholera  virus  intended 
for  the  inoculation  of  pigs  for  any  purpose  shall  be  collected  only 
from  pigs  which  are  observed  by  a  veterinary  inspector  to  be  visibly 
sick  with  hog  cholera  within  six  days  after  the  time  of  inoculation 
and  which  manifest  well-marked  and  increasingly  grave  symptoms 
of  hog  cholera  attended  with  progressively  abnormal  temperatures 
common  to  the  acute  type  of  this  disease. 

Paragraph  4-  Simultaneous  virus  and  virus  intended  for  inocula- 
tion purposes  shall  be  defibrinated  promptly  after  collection,  and 
immediately  thereafter  chilled  and  maintained  at  a  temperature  not 
to  exceed  5'5°  F.  (12.8°  C). 

Paragraph  5.  Should  it  become  necessary  under  the  provisions  of 
these  regulations  to  require  the  heating  of  simultaneous  virus  to  pre- 
vent the  possibility  of  disseminating  infections,  this  shall  be  accom- 
plished in  such  manner  as  may  be  prescribed  by  the  chief  of  bureau. 

Paragraph  6.  Simultaneous  virus  which  has  been  heated,  as  pro- 
vided in  the  preceding  paragraph,  shall  not  be  handled  thereafter  in 
a  manner  which  will  expose  the  product  to  contamination. 

Paragraph  7.  Simultaneous  virus  shall  be  tested  for  virulence  by 
inoculating  in  the  axillary  space  or  intramuscularly  with  2  cubic 
centimeters  of  the  virus  to  "be  tested,  each  of  four  or  more  pigs  which 
are  susceptible  to  hog  cholera.  Should  not  less  than  75  per  cent  of 
the  pigs  thus  inoculated  become  affected  with  hog  cholera  as  required 
for  pigs  inoculated  to  furnish  simultaneous  virus,  the  test  will  be 
declared  "  Satisfactory  for  virulence."  Should  this  test  be  found  un- 
satisfactory a  retest  may  be  made. 

Paragraph  8.  Pigs  selected  for  testing  the  virulence  of  simul- 
taneous virus  shall  be  inoculated  within  eight  hours  after  their 
admission  to  the  premises.  The  quarters  where  these  pigs  are  held 
during  the  test  shall  be  isolated  as  completely  as  feasible  from 
quarters  occupied  by  other  pigs  exposed  to  or  sick  with  hog  cholera. 
All  reasonable  precautions  shall  be  taken  to  prevent  infection  of 
these  pigs  from  sources  other  than  by  inoculation.  Such  precau- 
tions shall  include  a  thorough  cleaning  and  disinfection  of  the 
pens  in  which  the  pigs  are  held  on  the  premises,  and  a  disinfection 
of  these  animals  after  they  are  placed  in  holding  pens.  The  dis- 
infection of  these  pens  and  the  test  pigs  shall  be  accomplished  with 
a  2  per  cent  aqueous  solution  of  cresol  compound,  U.  S.  P.,  or  by 
such  methods  as  shall  be  approved  by  the  chief  of  bureau. 


21 

Section  4.  Paragraph  1.  Simultaneous  virus  shall  be  collected 
in  batches  of  not  to  exceed  20,000  cubic  centimeters  each  and  each 
batch  shall  be  mixed  thoroughly  in  a  single  container  before 
phenolization,  and  by  constant  agitation  during  the  bottling  process. 

Paragraph  2.  After  mixing,  but  before  phenolization,  a  repre- 
sentative sample  of  each  batch,  consisting  of  at  least  15  cubic 
centimeters  of  the  mixture,  shall  be  taken  by  a  bureau  employee. 
This  sample  shall  be  known  as  the  "  virus-test  sample." 

Paragraph  3.  Simultaneous  virus  which  has  been  mixed  as  pro- 
vided in  this  section,  after  withdrawal  of  the  "  virus-test  sample." 
shall  have  added  to  it  a  sufficient  quantity  of  a  5  per  cent  solution 
of  phenol  so  that  the  virus  will  contain  one-half  of  1  per  cent  phenol 
by  volume.  This  phenolization  must  be  accomplished  with  ac- 
curacy and  in  a  manner  which  will  prevent  undesirable  changes  in 
the  product.  After  thorough  mixing  in  a  single  container,  a  repre- 
sentative sample,  consisting  of  at  least  100  cubic  centimeters,  col- 
lected in  three  containers,  shall  be  taken  by  a  bureau  employee. 
This  sample  shall  be  known  as  the  "virus-stock  sample." 

Paragraph  Jf.  Simultaneous  virus  which  has  been  mixed  and 
phenolized,  as  provided  in  this  section,  together  with  the  virus- 
stock  sample  and  the  unused  residue  of  the  virus-test  sample,  shall 
be  placed  under  bureau  lock  and  held  as  provided  under  subdivi- 
sion (6),  section  1,  of  Regulation  7  until  such  time  as  required  test 
has  shown  the  batch  of  virus  to  be  virulent  as  prescribed  in  para- 
graph 7,  section  3,  of  this  regulation  and  free  from  contamination. 

Paragraph  5.  At  least  one  container  of  the  virus-stock  sample 
shall  be  held  unopened  under  bureau  lock,  in  the  manner  provided 
in  Regulation  7,  for  at  least  three  months  after  the  expiration  of 
the  latest  return  date  shown  upon  the  trade  labels  affixed  to  the 
immediate  or  true  containers  of  the  product  corresponding  to  the 
virus-stock  sample.  The  virus-test  sample  described  in  paragraph 
2  of  this  section  shall  be  used  to  determine  the  freedom'  from  con- 
tamination of  each  batch  of  simultaneous  virus. 

Paragraph  6.  Two  healthy  calves,  with  mouths  free  from  abra- 
sions, and  not  less  than  3  nor  more  than  12  months  old,  or  three 
healthy  pigs  immunized  by  the  simultaneous  treatment  against  hog 
cholera  for  at  least  21  days,  shall  be  furnished  by  the  establish- 
ment for  inoculation  with  the  virus-test  sample. 

Paragraph  7.  All  animals  used  for  the  testing  of  simultaneous 
virus  shall  be  inoculated  only  under  the  supervision  of  a  veter- 
inary inspector,  and  shall  be  marked  as  provided  in  paragraphs 
2,  3,  4,  and  5,  section  6,  of  Regulation  17. 

Paragraph  8.  Each  of  the  animals  selected  for  testing  the  purity 
of  simultaneous  virus  shall  be  inoculated  by  injecting  5  cubic 
centimeters  of  the  virus-test  sample  into  either  the  auricular  or  the 
jugular  vein  within  24  hours  after  the  virus  is  collected. 

Paragraph  9.  Animals  inoculated  for  the  purpose  of  determining 
the  purity  of  simultaneous  virus  as  provided  in  the  preceding  para- 
graph shall  be  held  under  the  observation  of  a  veterinary  inspector 
for  a  period  of  at  least  seven  days.  Should  foot-and-mouth  disease 
appear  in  the  United  States  the  said  animals  shall  be  held  under  the 
observation  of  a  veterinary  inspector  for  10  days  or  longer,  at  the 
discretion  of  the  inspector  in  charge. 


22 

Paragraph  10.  U  the  animals  which  are  treated  with  hog-cholera 
virus  as  prescribed  in  the  preceding  paragraph  of  this  section  do 
not  manifest  symptoms  of  any  infectious,  contagious,  or  communi- 
cable disease  except  as  hereinafter  provided,  the  test  will  be  declared 
"  Satisfactory  for  purity,''  and  if  the  product  has  been  found  "satis- 
factory for  virulence,"  as  defined  in  paragraph  7.  section  3,  of  this 
regulation,  it  will  be  released  for  marketing.  Should  any  of  the 
animals  in  the  test  succumb  or  should  more  than  one  develop  hog 
cholera,  another  test  should  be  made  as  in  the  first  instance,  except 
that  not  less  than  15  cubic  centimeters  of  the  virus  should  be  used  for 
the  inoculation  of  each  animal  if  the  virus  contains  preservative. 

Paragraph  11.  Simultaneous  virus  found  to  be  worthless  or  con- 
taminated shall  be  destroyed  as  provided  in  section  11,  Regulation 
8,  under  the  supervision  of  a  bureau  employee. 

Section  5.  Paragraph  1.  Each  immediate  or  true  container  of 
hog-cholera  virus  which  has  been  tested  and  not  found  to  be  worth- 
less or  contaminated  may  bear  over  the  opening  of  its  neck  a  paper 
cap  attached  by  the  establishment  and  on  which  may  appear  the  words. 
••  U.  S.  Released."  Whenever  caps  bearing  the  aforesaid  words  are 
applied,  they  shall  be  serially  numbered  and  bear  the  license  legend 
of  the  establishment  properly  separated  from  the  words  and  num- 
ber aforesaid.  It  shall  be  affixed  only  after  approval  thereof  by  the 
bureau  and  under  the  supervision  of  a  bureau  employee.  When  these 
caps  are  not  in  use  they  shall  be  held  under  bureau  lock.  Strong, 
flexible  bands  perforated  as  hereinafter  described  shall  be  used  to 
hold  the  aforesaid  caps  securely  over  the  openings  of  the  containers 
of  the  product.  All  perforations  of  said  bands  shall  consist  of  the 
number  of  the  license  under  which  the  product  is  produced,  a  number 
assigned  to  the  batch  to  which  the  perforated  band  is  affixed,  and  the 
last  figure  in  the  number  used  for  indicating  the  calendar  year. 
(Illustration:  190.18.2=License  Xo.  190:  batch  18;  year  1922.)  'The 
perforating  machine  when  not  in  use  for  perforating  bands  as  afore- 
said shall  be  held  under  bureau  lock. 

Paragraph  2.  The  trade  label  on  each  immediate  or  true  container 
of  simultaneous  virus  shall  bear  the  date  of  manufacture,  which  date 
shall  be  the  day  on  which  the  virus  is  collected. 

Paragraph  3.  The  return  date  placed  upon  the  label  of  each  im- 
mediate or  true  container  of  simultaneous  virus  shall  be  a  date  within 
60  days  after  the  date  of  manufacture. 

Paragraph  J+.  Trade  labels  affixed  to  or  used  in  connection  with  the 
immediate  or  true  containers  of  hog-cholera  virus  shall  show  plainly 
the  amount  of  the  contents  of  said  containers. 

Paragraph  5.  Trade  labels  affixed  to  or  used  in  connection  with 
each  immediate  or  true  container  of  simultaneous  virus  shall  bear  a 
dosage  table  in  whieh  the  doses  recommended  are  not  less  than  those 
appearing  in  the  following  table: 

Weight.  Minimum  dose. 

Pigs  weighing  45  pounds  or  less 1  c.  c. 

Pigs  weighing  more  than  45  pounds 2  c.  c. 

Paragraph  6.  No  hog-cholera  virus  shall  be  released  for  marketing 
unless  and  until  all  information  required  by  these  regulations  has 
been  affixed  to  the  containers  thereof  under  the  supervision  of  a 
bureau  employee. 


23 

REGULATION   19.— ANTI-HOG-CHOLERA  SERUM. 

Section  1.  Paragraph  1.  All  operations  incident  to  the  production 
of  anti-hog-cholera  serum  shall  be  conducted  under  the  supervision 
of  a  bureau  employee.  Each  licensed  establishment  shall  notify  the 
inspector  in  charge,  or  an  assistant,  a  reasonable  time  in  advance 
whenever  any  operations  are  to  be  conducted. 

Paragraph  2.  Principle :  Pigs  that  develop  hog  cholera  of  a  well- 
marked  and  progressive  type  attended  with  progressively  abnormal 
temperatures  produce  hog-cholera  virus  of  great  virulence,  and  when 
hogs  properly  immunized  against  hog  cholera  for  a  sufficient  length 
of  time  are  injected  intravenously  with  massive  quantities  of  such 
virus  their  blood  serum  is  possessed  of  superior  protective  proper- 
ties against  hog  cholera.  Therefore,  these  principal  facts  should 
form  the  basis  of  all  methods  of  producing  anti-hog-cholera  serum 
and  hog-cholera  virus  as  well  as  of  all  regulations  governing  their 
production. 

Section  2.  Paragraph  1.  Anti-hog-cholera  serum  shall  be  derived 
only  from  hyperimmune  hogs  which  have  been  immune  to  hog- 
cholera  for  at  least  90  days  prior  to  hyperimmunization. 

Paragraph  2.  Anti-hog-cholera  serum  shall  be  derived  only  from 
hyperimmune  hogs  which  have  been  subjected  to  not  more  than  4 
successive  bleedings  after  each  hyperimmunization.  The  first  bleed- 
ing shall  take  place  not  earlier  than  10  days  after  hyperimmuniza- 
tion. subsequent  bleedings  shall  not  take  place  more  frequently  than 
once  in  7  days,  and  the  last  bleeding  shall  be  made  on  a  date  not  later 
than  38  days  after  hyperimmunization. 

Paragraph  3.  Hogs  which  are  used  to  produce  anti-hog-cholera 
serum  shall  be  healthy  at  the  time  of  hyperimmunization,  this  fact 
to  be  determined  by  a  careful  examination  made  by  a  veterinary  in- 
spector prior  to  hyperimmunization.  The  temperature  and  weight 
of  each  animal  shall  be  accurately  obtained  and  recorded  by  the 
establishment  before  hyperimmunization. 

Paragraph  If.  All  hogs  which  are  used  to  produce  anti-hog-cholera 
serum  at  each  hyperimmunization  shall  receive  a  single  intravenous 
injection  of  at  least  5  cubic  centimeters  of  hog-cholera  virus  for  each 
pound  of  the  animal's  weight. 

Paragraph  5.  The  temperatures  of  all  hogs  used  to  produce  anti- 
hog-cholera  serum  shall  be  accurately  taken  with  reliable  thermom- 
eters and  recorded  by  licensed  establishments  either  on  the  afternoon 
before  or  on  the  day  of  bleeding  and  at  such  other  times  as  the  in- 
spector in  charge  may  deem  necessary.  All  temperatures  shall  be 
taken  under  normal  conditions  on  groups  of  hogs  to  be  bled  on  the 
same  date  and  without  undue  delay.  Clean,  light  quarters  equipped 
with  a  temperature  chute  and  all  other  needed  facilities  for  expedit- 
ing the  work  and  satisfactory  inspection  shall  be  provided. 

Paragraph  6.  All  hogs  which  are  used  to  produce  anti-hog-cholera 
serum  shall  be  subjected  to  a  careful  examination  by  a  veterinary  in- 
spector immediately  prior  to  each  bleeding.  Only  those  hogs  shall 
be  bled  for  serum  which  are  found  to  have  a  temperature  of  less  than 
104°  F.  and  are  free  from  infectious,  contagious,  or  communicable 
diseases  or  other  abnormal  conditions. 

Paragraph  7.  Anti-hcg-cholera  serum  derived  from  hogs  which 
after  hyperimmunization  manifest  symptoms  indicative  of  an  affec- 


24 

tion  of  a  constitutional  character  other  than  those  usually  observed 
immediately  following  hyperimmunization  shall  not  be  mixed  with 
other  serum  unless  after  consideration  of  the  prevailing-  conditions 
this  action  is  permitted  by  the  chief  of  bureau.  Such  serum,  if  col- 
lected only  from  hogs  as  prescribed  in  the  preceding  paragraph,  may 
be  mixed  alone  and  tested  as  prescribed  in  this  regulation,  and  if.  as 
a  result  of  this  test,  the  product  is  found  satisfactory,  it  may  be 
marketed.  Otherwise  the  serum  will  be  destroyed,  as  provided  in 
section  11,  Regulation  8,  under  the  supervision  of  a  bureau  employee. 

Paragraph  3.  All  hogs  from  which  anti-hog-cholera  serum  is  de- 
rived shall  be  subjected  to  a  post-mortem  examination  by  a  bureau 
employee.  Should  conditions  warrant  the  procedure,  trained  lay 
inspectors  may  be  authorized  by  the  inspector  in  charge  to  make  pre- 
liminary examinations  as  aforesaid,  but  the  carcasses  of  these  hogs 
should  be  retained  for  final  examination  b}T  a  veterinary  inspector, 
and  the  viscera  of  all  that  bear  evidence  of  any  abnormality  must  also 
be  subjected  to  examination  in  like  manner.  If.  as  a  result  of  such 
examination,  it  is  found  that  any  hog  is  so  affected  with  any  infec- 
tious, contagious,  or  communicable  disease  or  is  in  such  condition  as 
to  render  the  serum  worthless,  contaminated,  dangerous,  or  harmful, 
the  serum  collected  from  such  hogs  shall  be  destroyed  by  the  estab- 
lishment, as  provided  in  section  11,  Regulation  8,  under  the  supervi- 
sion of  a  bureau  employee,  except  that  serum  derived  from  tuber- 
culous hogs  need  not  be  so  destroyed  Avhen  the  lesions  are  slight  or 
are  localized  and  are  calcified  or  encapsulated,  or  when  the  product 
from  tuberculous  hogs  is  clarified  and  heated  or  tested  by  methods 
approved  by  the  chief  of  bureau,  or  when  refined  and  heated  or  tested 
as  aforesaid. 

Paragraph  9.  Anti-hog-cholera  serum  derived  from  each  hyper- 
immune hog  shall  be  kept  separate  and  apart  from  other  serum  except 
when  heated  as  prescribed  in  paragraph  11  of  this  section,  until  it 
has  been  determined  by  post-mortem  examination  that  the  hog  from 
which  the  serum  is  derived  is  not  so  affected  with  any  infectious,  con- 
tagious, or  communicable  disease  or  is  in  such  condition  as  to  render 
the  serum  worthless,  contaminated,  dangerous,  or  harmful. 

Paragraph  10.  When  anti-hog-cholera  serum  is  heated  as  described 
in  the  following  paragraph  the  serum  derived  from  each  hyperim- 
mune hog  may  be  mixed  with  serum  from  other  hyperimmune  hogs 
immediately  after  collection,  provided  the  final  batch  or  mixture  is 
prepared  and  handled  as  prescribed  in  the  following  paragraph  of 
this  section. 

Paragraph  11.  Heating  of  anti-hog-cholera  serum  shall  be  con- 
ducted under  the  supervision  of  a  bureau  employee  and  in  a  manner 
in  which  the  product  and  the  entire  container  thereof  will  be  sub- 
jected to  a  temperature  ranging  from  59°  to  60°  C.  for  30  minutes. 

Paragraph  12.  Anti-hog-cholera  serum  which  has  been  heated  as 
provided  in  the  preceding  paragraph  shall  not  be  handled  thereafter 
in  a  manner  which  will  expose  the  product  to  contamination.  Final 
mixtures  or  batches  of  anti-hog-cholera  serum  shall  contain  relative 
proportions  of  the  several  bleedings.  Single  bleedings  from  each 
hog  shall  not  be  divided  or  become  a  part  of  two  or  more  batches 
unless  the  serum  is  subjected  to  heat  as  described  in  paragraph  11  of 
this  section. 


25 

Paragraph  IS.  Whenever  practicable,  all  the  blood  from  a  given 
number  of  hyperimmune  hogs  should  be  placed  in  the  same  batch, 
but.  in  order  that  the  batch  may  closely  approximate  100,000  cubic 
centimeters,  as  many  individual  bleedings  of  any  one  hog's  blood 
as  required  for  this  purpose  may  be  used  and  the  remainder,  if  any. 
of  such  individual  hog's  blood  should  be  placed  in  another  single 
hatch.  In  selecting  a  bleeding  for  this  purpose  the  one  which  will 
cause  the  batch  most  closely  to  approximate  100.000  cubic  centimeters 
should  be  used. 

Paragraph  H.  Anti-hog-cholera  serum  which  is  to  constitute  a 
batch  or  portion  thereof  may  be  strained  into  a  single  container, 
after  which  the  amount  should  be  accurately  determined. 

Paragraph  15.  Ordinary  deiibrinated  blood  anti-hog-cholera 
serum  shall  have  added  thereto  a  sufficient  quantity  of  a  5  per  cent 
solution  of  phenol  to  make  the  completed  serum  contain  one-half 
of  1  per  cent  phenol  by  volume.  Clear  anti-hog-cholera  serum  shall 
be  preserved  likewise,  unless  otherwise  permitted  by  the  chief  of 
bureau. 

Paragraph  16.  Phenolization  of  anti-hog-cholera  serum  must  be 
accomplished  with  accuracy,  and  in  a  manner  which  will  prevent 
the  occurrence  of  undesirable  changes  in  the  product. 

Paragraph  17.  All  records  shall  indicate  clearly  the  particular 
hog  or  group  of  hogs  from  which  each  batch  of  serum  or  portion 
thereof  is  derived.  The  amount  prepared  for  phenolization  and  the 
total  amount  after  phenolization  shall  be  separately  recorded. 

Sectiox  3.  Paragraph  1.  Anti-hog-cholera  serum  prior  to  testing 
shall  be  collected  in  batches  of  not  more  than  approximately  100.000 
cubic  centimeters  each,  which  shall  be  thoroughly  mixed  in  a  single 
container,  by  constant  agitation  during  the  bottling  process.  After 
mixing  and  phenolizing,  a  representative  sample  consisting  of  at 
least  375  cubic  centimeters  collected  in  three  containers  of  not  less 
than  125  centimeters,  each  to  be  known  as  the  "  serum-test  sample." 
shall  be  taken  and  marked  with  identifying  marks  by  a  bureau 
employee.  The  serum,  together  with  the  test  sample,  shall  be 
placed  under  bureau  lock,  as  provided  under  subdivision  (h)  section 
1.  Regulation  7.  and  so  held  until  such  time  as  the  tests  required  by 
these  regulations  have  been  completed,  and  have  indicated  that 
the  serum  is  not  worthless,  contaminated,  dangerous,  or  harmful. 

Paragraph  2.  If  the  serum  is  released,  one  of  the  three  containers 
of  the  test  sample  thereof  shall  be  held  under  bureau  lock  for  at 
least  six  months  after  the  latest  return  date  shown  on  the  trade 
labels  affixed  to  the  immediate  or  true  containers  of  the  serum  of 
which  the  test  sample  is  a  part. 

Paragraph  3.  Test  samples  of  anti-hog-cholera  serum  on  which 
the  return  date  has  expired  six  months  previously  may  be  labeled 
and  marketed  in  the  regular  manner,  provided  it  is  feasible,  within 
two  years  after  the  first  serum  composing  the  batch  is  collected. 
When  not  feasible,  and  it  is  desired  to  market  the  serum,  the 
samples  should  be  mixed  and  assigned  a  serial  number.  This  mix- 
ture may  be  tested  alone  or  it  may  be  mixed  with  other  untested 
serum  and  tested  as  prescribed  in  sections  4  and  5  of  this  regulation 
provided  the  latter  does  not  represent  more  than  50  per  cent  of  the 
serum  contained  in  the  final  mixture.     The  return  date  to  be  affixed 


26 

to  the  containers  of  mixtures  of  test  samples  should  not  exceed  one 
year  from  the  date  of  conclusion  of  a  satisfactory  test  for  potency. 

Sfxtion  4.  Paragraph  1.  All  anti-hog-cholera  serum  shall  be  tested 
for  purity  and  potency  by  licensed  establishments  as  prescribed  by 
these  regulations. 

Paragraph  2.  For  use  in  testing  each  batch  of  100,000  cubic  centi- 
meters of  anti-hog-cholera  serum  or  less,  eight  healthy  pigs,  sus- 
ceptible to  hog  cholera  and  weighing  not  less  than  40  pounds  and  not 
more  than  90  pounds  each,  shall  be  furnished  by  the  establishment, 
except  as  provided  in  sections  7.  8,  and  9  of  this  regulation. 

Paragraph  3.  Each  of  the  eight  pigs  furnished  for  the  test  shall 
be  injected  with  2  cubic  centimeters  of  hog-cholera  virus;  of  these 
pigs,  five  shall  receive  20  cubic  centimeters  of  the  serum  which  is 
to  be  tested.  Three  of  the  pigs  shall  receive  no  serum  and  shall  serve 
as  controls.  The  virus  and  serum  injections  shall  be  made  simul- 
taneously, the  virus  being  injected  into  the  left  axillary  space,  and 
the  serum  into  the  right.  The  same  virus  shall  be  used  for  the 
inoculation  of  all  pigs  in  the  test  and  shall  be  selected  and  adminis- 
tered by  a  veterinary  inspector. 

Paragraph  1±.  A  veterinary  inspector  shall  indicate  the  pigs  which 
shall  receive  serum  with  virus  and  those  which  shall  receive  the 
virus  only  in  each  serum  test. 

Paragraph  5.  All  surviving  pigs  used  for  testing  a  batch  of  serum 
shall  be  subjected  to  the  same  conditions  throughout  the  test  period 
and  shall  be  held  in  a  single  pen  or  inclosure  throughout  this  period 
except  when  it  is  evident  that  a  test  of  serum  will  be  declared  "  No 
test "  or  "  Unsatisfactory  for  potency,"  the  test  pigs,  with  the  per- 
mission of  a  bureau  employee,  may  be  removed  from  the  original 
test  pen  and  placed  with  other  pigs  of  the  same  class  in  a  common 
pen  for  the  purpose  of  releasing  test  pen  space  for  other  tests. 

Paragraph  6.  The  period  for  holding  surviving  pigs  under  the 
observation  of  a  bureau  employee,  while  being  used  for  testing  the 
potency  and  purity  of  anti-hog-cholera  serum  as  described  in  this 
regulation,  shall  be  not  less  than  21  days  immediately  following 
their  inoculation  for  this  purpose,  and  as  much  longer  as  the  inspector 
in  charge  deems  necessary  to  render  proper  judgment  of  the  results 
of  the  test.  If  not  more  than  one  serum-treated  pig  succumbs  within 
15  days  after  inoculation,  however,  or  if  it  becomes  necessary  to 
retest  a  batch  of  serum  for  purity  only,  15  days  immediately  follow- 
ing the  inoculation  of  the  pigs  will  constitute  the  period  for  testing 
the  purity  of  the  product. 

Paragraph  7.  Pigs  in  serum  tests  shall  be  held  under  the  obser- 
vation of  a  veterinary  inspector  and  shall  not  be  removed  from  the 
test  unless  and  until  released  by  such  an  inspector,  who  will  permit 
their  removal  after  they  have  served  their  purpose  in  the  test  as 
prescribed  in  this  regulation. 

Paragraph  8.  The  temperature  of  each  pig  used  in  a  test  of  anti- 
hog-cholera  serum  shall  be  taken  and  recorded  shortly  before  each 
test  is  started. 

Paragraph  D.  Temperatures  of  control  pigs  and  "slow"  or  sick 
serum-treated  pigs  in  serum  tests,  excepting  known  "  Unsatisfactory 
tests  "  and  "  No  tests,"  shall  be  taken  daily  throughout  the  test  period, 
but  not  on  Sundays  and  holidays  when  these  days  are  of  no  particular 
consequence  to  the  proper  disposition  of  the  test,  and  an  accurate 


27 

report  of  these  temperatures  shall  be  rendered  by  the  establishment 
to  the  inspector  in  charge  as  he  may  direct. 

Paragraph  10.  When  serum-treated  pigs  do  not  manifest  "  slow- 
ness "  or  symptoms  of  sickness  their  temperatures  need  not  be  taken 
except  when  required  by  the  inspector  in  charge  or  his  assistant  to 
determine  more  accurately  the  true  physical  condition  of  the  animals 
under  observation. 

Paragraph  11.  Simultaneous  virus  or  its  equivalent  of  high  viru- 
lence and  in  sufficient  quantities  to  meet  the  needs  shall  be  furnished 
by  licensed  establishments  for  use  as  the  inspector  in  charge  may 
deem  advisable  for  inoculating  pigs  in  serum  tests.  Virus  furnished 
by  licensed  establishments  shall  not  be  used  in  a  serum  test  if  it  has 
been  collected  for  more  than  30  days  previous  to  the  inauguration  of 
the  test,  but  tests  of  virus  required  by  these  regulations  shall  not 
operate  to  prevent  the  use  of  the  product  in  serum  tests  at  any  time 
within  30  days  after  its  collection. 

Paragraph  12.  Hog-cholera  virus  furnished  by  the  Bureau  of 
Animal  Industry  ma}^  be  used  in  inoculating  pigs  in  tests  whenever 
the  inspector  in  charge  deems  this  procedure  advisable,  and  When- 
ever conditions  in  previous  tests  of  any  batch  of  serum  have  indi- 
cated some  deficiency  in  either  the  virus  or  serum  used. 

Section  5.  Paragraph  1.  The  following  principle  and  rules  are 
declared  for  a  guide  in  judging  the  results  of  serum  tests : 

Principle:  It  is  practically  impossible  in  many  cases  to  differenti- 
ate accurately  between  hog  cholera,  pneumonia,  and  other  conditions 
affecting  hogs  without  the  aid  of  an  autopsy  as  well  as  applied  labora- 
tory technic  and  certain  experiments  which  may  be  necessary  to 
determine  the  causative  agent  responsible  for  the  condition.  There- 
fore, when  healthy  pigs  are  selected  for  testing  anti-hog-cholera 
serum  any  abnormal  condition  which  may  arise  in  the  pigs  subse- 
quent to  their  inoculation  should  be  regarded  as  due  either  to  the 
virus  used  or,  in  the  case  of  the  serum-treated  pigs,  to  the  fact  that 
the  serum  does  not  protect,  unless  the  condition  is  definitely  known 
or  can  be  shown  to  be  due  to  some  other  cause. 

Paragraph  2.  The  following  rules  shall  be  observed  in  disposing 
of  anti-hog-cholera  serum  which  has  been  subjected  to  the  tests  pre- 
scribed by  these  regulations : 

Rule  A.  The  purpose  of  control  pigs  in  serum  tests  will  be  to 
furnish  information  as  to  the  virulence  of  the  virus  used  for  inocu- 
lating the  animals  and  to  indicate  whether  the  pigs  furnished  are 
properly  susceptible  to  hog  cholera.  As  an  aid  for  determining  the 
fulfillment  of  this  purpose  the  following  conditions  shall  obtain : 

1.  At  least  two  of  the  control  pigs  shall  become  visibly  sick  of  hog 
cholera  subsequent  to  the  third  day  of  the  test  period  and  within 
seven  days  after  the  test  is  inaugurated. 

2.  At  least  two  of  the  control  pigs  which  become  sick  as  described 
in  the  preceding  paragraph  of  this  rule  shall  manifest  well-marked 
and  increasingly  grave  symptoms  of  hog  cholera  attended  with  pro- 
gressively abnormal  temperatures  common  to  the  acute  type  of  this 
disease. 

3.  At  least  two  of  the  control  pigs,  which  become  sick  as  described 
in  the  preceding  paragraphs  of  this  rule,  shall  show  lesions  upon 
post-mortem   examination   sufficient    for   a   veterinary   inspector   to 


28 

make  a  positive  diagnosis  of  hog  cholera,  when  considered  with  the 
ante-mortem  behavior  of  these  animals. 

Rule  B.  A  serum  test  will  be  declared  "  Satisfactory  for  potency  " 
when  at  least  two  of  the  control  pigs  react  as  described  in  rule  A  of 
this  regulation  and  any  one  of  the  following  conditions  obtains: 

1.  When  all  the  serum-treated  pigs  remain  well  throughout  the 
test  period. 

2.  When  not  more  than  one  of  the  serum-treated  pigs  becomes 
visibly  sick  after  the  time  of  inoculation  and  fully  recovers  before, 
the  test  animals  are  released  by  a  veterinary  inspector  as  provided  in 
this  regulation.  Such  a  sick  pig,  however,  will  not  be  regarded  as 
having  fully  recovered  until  it  has  been  in  an  apparently  normal 
condition  for  at  least  three  days. 

Rule  C.  A  serum  test  will  be  declared  "  Unsatisfactory  for  po- 
tency "  when  at  least  two  of  the  control  pigs  react  as  described  in 
rule  A  of  this  regulation  and  any  one  of  the  following  conditions 
obtains : 

1.  When  one  of  the  serum-treated  pigs  becomes  visibly  sick 
subsequent  to  the  third  day  after  the  time  of  inoculation  and  is 
found  not  to  have  fully  recovered  before  the  test  animals  are  re- 
leased by  a  veterinary  inspector  as  provided  in  this  regulation. 

2.  When  two  or  more  of  the  serum-treated  pigs  become  visibly 
sick  subsequent  to  the  third  clay  after  the  time  of  inoculation. 

Rule  D.  A  serum  test  will  be  declared  "  No  test  for  potency  *' 
when  any  one  of  the  following  conditions  obtains,  but  such  action 
will  not  operate  to  prevent  a  retest  under  the  provisions  of  these 
regulations. 

1.  When  one  of  the  serum-treated  pigs  becomes  visibly  sick  on 
or  before  the  third  day  after  the  time  of  inoculation  and  fails  to 
recover  within  the  test  period. 

2.  When  two  or  more  of  the  serum-treated  pigs  or  two  or  all 
of  the  control  pigs  become  visibly  sick  on  or  before  the  third  day 
after  the  time  of  inoculation. 

3.  When  two  or  all  of  the  control  pigs  do  not  manifest  symptoms 
of  hog  cholera  as  described  in  rule  A  of  this  regulation. 

4.  When  two  or  all  of  the  control  pigs  do  not  show  lesions  of  hog 
cholera  upon  post-mortem  examination  as  described  in  rule  A  of 
this   regulation. 

5.  When  two  or  all  of  the  control  pigs  manifest  symptoms  of  hog 
cholera  within  seven  days  as  described  in  rule  A  of  this  regulation 
but  do  not  become  sick  to  the  degree  described  in  said  rule. 

6.  When  the  serum-treated  pigs  develop  during  the  test  period 
symptoms  of  any  infectious,  contagious,  or  communicable  disease 
(other  than  hog  cholera)  which  is  not  caused  by  the  serum  used. 

7.  When  a  condition  obtains  in  any  of  the  test  pigs  which  is 
not  otherwise  covered  in  this  section. 

Rule  E.  A  serum  test  will  be  declared  "  Satisfactory  for  purity  " 
when  the  following  condition  obtains: 

1.  When  not  more  than  one  of  the  serum-treated  pigs  in  the  test 
develops  an  abscess  at  the  site  of  the  serum  injection  and  no  symp- 
toms of  any  infectious,  contagious,  or  communicable  disease  other 
than  hog  cholera  are  manifested  by  any  of  the  animals  in  the  test. 

Rule  F.  A  serum  test  will  be  declared  "Unsatisfactory  for  pur- 
ity "  when  either  of  the  following  conditions  obtains : 


29 

1.  When  abscesses  which  are  not  definitely  known  to  be  due  to 
causes  other  than  the  serum  used  develop  at  the  sites  of  the  serum 
injections  in  more  than  one  of  the  serum-treated  pigs. 

2.  When  during  the  test  period  any  of  the  serum-treated  test 
pigs  develop  symptoms  of  any  infectious,  contagious,  or  communi- 
cable disease  (other  than  hog  cholera)  which  is  due  to  the  serum 
used. 

Rule  G.  A  serum  test  will  be  declared  "No  test  for  purity" 
when  any  one  of  the  following  conditions  obtains,  but  such  action 
will  not  operate  to  prevent  a  retest  under  the  provisions  of  these 
regulations. 

1.  When  two  or  more  of  the  serum-treated  pigs  succumb  within 
15  days  after  the  time  of  inoculation. 

2.  When  the  serum-treated  pigs  develop  during  the  test  period 
symptoms  of  any  infectious,  contagious,  or  communicable  dis- 
ease (other  than  hog  cholera)  which  is  not  caused  by  the  serum 
used. 

3.  WTien  a  condition  obtains  in  any  of  the  test  pigs  which  is  not 
otherwise  covered  in  this  section. 

Section  6.  Paragraph  1.  Anti-hog-cholera  serum  may  be  released 
for  marketing  as  hereinafter  prescribed  when  the  tests  required  by 
this  regulation  are  found  to  be  satisfactory  as  denned  in  rules  B 
and  E  hereof,  provided  the  product  is  recommended  for  use  in  doses 
not  less  than  those  appearing  in  the  following  table.  This  table  shall 
be  a  part  of  trade  labels,  wrappers,  and  the  like,  affixed  to  or  used 
in  connection  with  each  immediate  or  true  container  of  the  product. 

Weight.  Minimum  dose. 

Sucking  pigs 20  c.  c. 

Pigs  20  to  40  pounds 30  c.  c. 

Pigs  40  to  90  pounds 35  c.  c. 

Pigs  90  to  120  pounds 45  c.  c. 

Hogs  120  to  150  pounds 55  c.  c. 

Hogs  150  to  180  pounds 65  c.  c. 

Hogs  180  pounds  and  over 75  c.  c. 

Paragraph  2.  Anti-hog-cholera  serum  the  test  of  which  has  proved 
it  to  be  "Unsatisfactory  for  potency,"  as  defined  in  rule  C  of  this 
regulation,  may  be  tested  again  as  described  in  sections  4  and  5  of 
this  regulation.  Should  the  second  test  prove  to  be  "  Satisfactory 
for  potency,''  as  defined  in  rule  B,  the  serum  may  be  released  for 
marketing  under  the  condition  set  forth  in  paragraph  1  of  this  sec- 
tion. If  the  test  is  again  found  "Unsatisfactory  for  potency,"  as 
defined  in  rule  C,  the  serum  shall  not  be  marketed  unless  and  until  it 
is  either  refined,  concentrated,  and  tested  in  a  manner  approved  by 
the  chief  of  bureau,  or  mixed  with  other  serum  and  tested  as  pro- 
vided in  section  7  of  this  regulation. 

Section  7.  Paragraph  1.  Anti-hog-cholera  serum  found  twice 
"  Unsatisfactory  for  potency  "  as  described  in  rule  C  of  this  regula- 
tion but  which  is  "  Satisfactory  for  purity "  as  described  in  rule  E 
hereof  may  be  mixed  with  other  anti-hog-cholera  serum  with  the 
view  of  increasing  its  potency  and  the  final  mixture  shall  consist  of 
not  less  than  50  per  cent  nor  more  than  60  per  cent  of  the  serum  of 
doubtful  potency  in  the  case  of  ordinary  defibrinated-blood  serum. 
Clear  serum  found  "  Unsatisfactory  for  potency  "  as  aforesaid  should 
not  be  mixed  with  other  serum  except  as  may  be  permitted  by  the 
chief  of  bureau. 


30 

Paragraph  &  Anti-hog-cholera  serum  which  has  been  mixed  as 
provided  in  the  preceding  paragraph  shall  be  tested  as  outlined  in 
sections  4  and  5  of  this  regulation.  with  the  exception  that  11  pigs  in 
kieu  of  8  shall  be  used  and  8  of  these  shall  receive  serum. 

Paragraph  ■).  A  second  test,  conducted  in  the  same  manner  as  be- 
fore, may  be  made  of  serum  mixed  as  provided  in  paragraph  1  of 
this  section,  should  the  results  of  the  test  of  the  mixture  be  declared 
"Unsatisfactory  for  potency.''  Should  the  second  test  also  prove 
to  be  "  Unsatisfactory  for  potency"  the  product  shall  not  be  mar- 
keted unless  and  until  it  is  refined,  concentrated,  and  tested  in  a 
manner  approved  by  the  chief  of  bureau. 

Section  8.  Paragraph  1.  Should  abscesses  develop  at  the  sites  of 
the  serum  inoculations  in  any  of  the  pigs  used  for  testing  serum  as 
provided  in  this  regulation,  the  following  rules  shall  apply: 

(a)  Judgment  of  the  results  of  tests  made  on  pigs  to  determine  the 
potency  of  anti-hog-cholera  serum  will  be  rendered  irrespective  of 
those  conditions  found  which  are  regarded  as  an  index  to  the  purity 
of  the  product. 

(b)  Should  the  results  of  a  test  of  anti-hog-cholera  serum  be  de- 
clared "  Satisfactory  for  purity,"  and  it  is  found  necessary  to  sub- 
ject the  batch  of  serum  to  a  retest  to  determine  its  potency,  judgment 
concerning  the  purity  of  the  product  shall  be  based  upon  the  first 
test  unless  evidence  is  found  subsequent  to  such  test  which  indicates 
that  the  serum  is  in  fact  contaminated. 

(c)  Anti-hog-cholera  serum  which  has  been  found  "Unsatisfac- 
tory for  purity"  as  defined  in  subdivision  1.  rule  F.  of  this  regula- 
tion, may  be  tested  again  for  purity  upon  eight  pigs,  provided  each 
pig  receives  a  single  injection,  in  the  axillary  space,  of  at  least  20 
cubic  centimeters  of  the  product  to  be  tested.  Immune  pigs  may  be 
used  for  this  test,  provided  the  product  has  already  been  found 
,;  Satisfactory  for  potency." 

Section  9.  Paragraph  1.  Anti-hog-cholera  serum  which  has  been 
found  twice  "  Unsatisfactory  for  purity  "  as  defined  in  subdivision  1, 
rule  F,  of  this  regulation,  but  which  is  "  Satisfactory  for  potency," 
as  prescribed  in  rule  B  hereof,  may  be  tested  again  with  the  view 
of  ascertaining  whether  it  is  in  fact  contaminated  with  pus-producing 
organisms,  by  treating  50  hogs  on  the  premises  of  the  manufacturing 
establishment.  The  serum  shall  be  administered  under  the  super- 
vision of  a  bureau  employee,  and  each  hog  treated  shall  receive  a 
single  injection,  in  the  axillary  space,  of  not  less  than  25  cubic  centi- 
meters of  the  product  to  be  tested. 

Paragraph  2.  Animals  used  for  testing  serum  as  prescribed  in 
paragraph  1  of  this  section  shall  be  held  under  the  supervision  of 
a  bureau  employee  for  at  least  15  days,  and  each  animal  carefully 
examined  at  the  sites  of  the  inoculations  to  determine  whether  the 
product  has  caused  abscess  formation.  Serum  tested  as  prescribed 
in  this  section  will  be  disposed  of  as  approved  by  the  chief  of  bureau. 

Section  10.  Paragraph  1.  Blood  derived  from  hyperimmune  hogs 
and  ordinary  defibrinated  blood  anti-hog-cholera  serum  may  be 
clarified  or  refined  and  concentrated  by  licensed  establishments,  pro- 
vided methods  used  to  accomplish  this  are  approved  by  the  chief  of 
bureau. 


31 

Paragraph  2.  When  hyperimmune  blood  and  ordinary  defibrinated 
blood  anti-hog-cholera  serum  that  has  not  been  found  "  Unsatisfac- 
tory for  potency  "  are  to  be  clarified  or  refined,  the  following  require- 
ments shall  be  observed : 

(a)  When  unconcentrated  clear  serum  is  prepared,  the  completed 
product  shall  contain  not  less  than  65  per  cent  of  true  serum  and 
shall  represent  not  more  than  98  per  cent  of  the  original  volume  of 
ordinary  serum  refined  or  the  possible  yield  of  ordinary  serum  ob- 
tainable under  these  regulations  from  the  hyperimmune  blood  used. 

(&)  When  concentrated  clear  serum  is  prepared,  the  completed 
product  shall  contain  not  less  than  80  per  cent  of  true  serum  and 
represent  not  more  than  78  per  cent  of  the  original  volume  of  ordi- 
nary serum  refined,  or  the  possible  yield  of  ordinary  serum  obtainable 
under  these  regulations  from  the  hyperimmune  blood  used. 

(c)  When  whole  blood  is  clarified,  3  per  cent  shall  be  allowed  for 
fibrin  contained  therein  when  calculating  the  possible  yield  of  ordi- 
nary serum. 

(d)  Unconcentrated  clear  serum  shall  be  tested  as  prescribed  in 
sections  4  and  5  of  this  regulation  and  the  immediate  or  true  con- 
tainers thereof  bear  recommendations  for  minimum  doses  prescribed 
in  paragraph  1.  section  6.  hereof. 

(e)  Concentrated  clear  serum  shall  be  tested  as  prescribed  in  sec- 
tions 4  and  5  of  this  regulation  except  that  if  it  is  desired  to  market 
the  product  in  doses  smaller  than  those  indicated  in  paragraph  1. 
section  6,  of  this  regulation,  the  pigs  in  the  test  shall  receive  15  cubic 
centimeters  of  the  product  to  be  tested. 

Paragraph  3.  Ordinary  defibrinated  blood  anti-hog-cholera  serum 
which  has  been  found  "  Unsatisfactory  for  potency  "  or  "  Unsatis- 
factory for  purity.'"  or  which  is  derived  from  tuberculous  hogs,  may 
be  refined  and  concentrated  by  licensed  establishments  in  accord- 
ance with  methods  approved  by  the  chief  of  bureau,  provided  solu- 
tions other  than  those  necessary  and  permitted  in  the  refinement  of 
the  product  are  not  added  to  serum  previously  found  "  Unsatisf ac- 
tor}7 for  potency."  The  completed  product  shall  be  tested  as  pro- 
vided in  sections  4  and  5  of  this  regulation  and  when  derived  from 
tuberculous  hogs  shall  be  heated  as  prescribed  in  paragraph  11.  sec- 
tion 2,  of  this  regulation,  or  tested  on  guinea  pigs,  as  approved  by 
the  chief  of  bureau.  The  immediate  or  true  containers  of  the 
product  shall  bear  a  minimum  dosage  table  applicable  under  the  pro- 
visions of  this  regulation  except  that  serum  which  before  refinement 
and  concentration  was  declared  "Unsatisfactory  for  potency  "  shal} 
bear  a  dosage  table  only  in  accord  with  the  terms  of  paragraph  1. 
section  6,  hereof. 

Paragraph  4-  Should  the  tests  required  by  this  regulation  be  found 
"  Satisfactory  for  potency  "  and  ,;  Satisfactory  for  purity."  as  de- 
fined in  rules  B  and  E  hereof,  and  the  test  pigs  receive  doses  of  the 
serum  as  prescribed  in  subdivision  (e) .  paragraph  2.  of  this  section, 
the  product  may  be  marketed  if  it  is  recommended  for  use  in  doses 
not  less  than  those  appearing  in  the  following  table.  This  table 
shall  be  a  part  of  trade  labels,  wrappers,  and  the  like,  affixed  to  or 
used  in  connection  with  each  immediate  or  true  container  of  the 
product : 


32 

Weight.  Minimum  dose. 

Sucking   pips 15  c.c. 

Pigs  20  to  40  pounds 25  c.  <•. 

Tips  40  to  00  pounds 30  c.  c. 

Pips  90  to  120  pounds 35  c.  c. 

Hops  120  to  150  pounds 45  c.c. 

Hops  150  to  180  pounds 50  c.c. 

Hops  180  pounds  and  over 60  c.c. 

Section  11.  Paragraph  1.  Each  immediate  or  true  container  of 
anti-hog-cholera  serum  which  has  been  tested  and  not  found  to  be 
worthless,  contaminated,  dangerous,  or  harmful  may  bear  over  the 
opening  of  its  neck  a  paper  cap  attached  by  the  establishment  and 
on  which  ma}'  appear  the  words  "  XT.  S.  Released."  Whenever  caps 
bearing  the  aforesaid  words  are  applied  they  shall  be  serially  num- 
bered and  bear  the  license  legend  of  the  establishment  properly 
separated  from  the  words  and  number  aforesaid.  It  shall  be  affixed 
only  after  approval  thereof  by  the  bureau  and  under  the  supervision 
of  a  bureau  employee.  When  these  caps  are  not  in  use  as  described 
they  shall  be  held  under  bureau  lock.  Strong,  flexible  bands,  per- 
forated as  hereinafter  described,  shall  be  used  to  hold  the  aforesaid 
caps  securely  over  the  openings  of  the  containers  of  the  product. 
All  perforations  of  said  bands  shall  consist  of  the  number  of  the 
license  under  which  the  product  is  produced;  a  number  assigned  to 
the  batch  to  which  the  perforated  band  is  affixed ;  and  the  last  figure 
in  the  number  used  for  indicating  the  calendar  year.  The  perforat- 
ing machine,  when  not  in  use  for  perforating  bands  as  aforesaid, 
shall  be  held  under  bureau  lock. 

Paragraph  #.  The  return  date  placed  upon  trade  labels  of  anti- 
hog-cholera  serum  shall  be  a  date  not  more  than  two  years  after  the 
date  of  bleeding.  The  date  of  bleeding  shall  be  regarded  as  the  date 
upon  Avhich  the  first  serum  was  collected,  which  is  a  part  of  the 
batch. 

Paragraph  3.  Should  the  return  date  of  any  batch  of  anti-hog- 
cholera  serum  expire  before  the  serum  is  used,  the  serum  should  be 
retested,  and  if  found  "  Satisfactory  for  potency  "  and  "  Satisfactory 
for  purity,"  as  defined  in  rules  B  and  E  hereof,  the  return  date  may 
be  extended  for  one  year  from  the  date  of  conclusion  of  the  retest 
for  potency. 

Paragraph  4.  Should  a  batch  of  anti-hog-cholera  serum  not  be 
found  "Satisfactory  for  potency"  or  " Satisfactory  for  purity"  before 
the  expiration  of  two  years  from  the  date  of  collection  of  the  oldest 
serum  in  the  batch,  or  not  in  time  to  allow  it  to  be  used  before  the 
expiration  of  two  years,  the  return  date  will  be  limited  to  six  months 
from  the  date  of  conclusion  of  a  satisfactory  test  for  potency. 

Paragraph  5.  Trade  labels  affixed  to  or  used  in  connection  with 
the  immediate  op  true  containers  of  anti-hog-cholera  serum  shall 
plainly  show  the  quantity  of  the  contents  of  said  containers. 

Paragraph  6.  No  immediate  or  true  container  of  anti-hog-cholera 
serum  shall  be  filled  in  whole  or  in  part,  and  no  trade  label  shall  be 
affixed  to  such  containers,  except  under  the  supervision  of  a  bureau 
employee. 

Paragraph  7.  Anti-hog-cholera  serum  shall  not  be  removed  from 
the  premises  of  a  licensed  establishment  unless  it  has  been  prepared 
in  accordance  with  the  provisions  of  these  regulations. 


33 

Paragraph  8.  No  anti-hog-cholera  serum  shall  be  released  for 
marketing  unless  and  until  all  the  information  required  by  these 
regulations  has  been  affixed  to  the  containers  thereof  under  the  super- 
vision of  a  bureau  employee. 

Section  12.  The  following  special  facilities  and  such  others  as 
may  be  required  by  the  chief  of  bureau  shall  be  provided  by  each 
establishment  licensed  to  prepare  anti-hog-cholera  serum. 

(a)  Separate  operating  rooms. 

(b)  A  separate  room  in  which  the  hog  shall  be  washed,  cleaned, 
and  otherwise  prepared  before  being  taken  into  the  operating  room. 

(c)  A  separate  room  for  conducting  autopsies. 

(d)  A  separate  room  for  the  preparation  and  mixing  of  serum. 

(e)  A  separate  room  for  washing  and  sterilizing  equipment. 

(/)  Clean  cloths,  which  shall  be  kept  damp  when  in  use,  to  be 
used  for  covering  hogs  during  all  operations  incident  to  the  collec- 
tion of  anti-hog-cholera  serum. 

(g)  All  outside  doors,  windows,  or  other  openings  shall  be 
equipped  with  dust  screens. 

Section  13.  All  persons  immediately  before  entering  the  operating 
or  laboratory  rooms  of  an  establishment  licensed  to  prepare  anti- 
hog-cholera  serum  when  these  rooms  are  in  use  shall  change  their 
outer  clothing  or  effectively  cover  the  same  by  the  use  of  gowns  or 
other  satisfactory  garments. 

REGULATION  20.— BACTERINS,  VACCINES,  TOXINS,  ETC. 

Section  1.  Paragraph  1.  Viruses  entering  into  the  preparation  of 
bacterins,  vaccines,  or  toxins  shall  be  derived  from  animals  which  are 
affected  with  no  disease  other  than  that  for  which  the  bacterins,  vac- 
cines, or  toxins  are  intended  to  be  used. 

Paragraph  %.  All  bacterins,  vaccines,  and  toxins  shall  be  derived 
from  the  specific  cause  of  the  diseases  for  which  they  are  intended  to 
be  used  or  from  the  secondary  invaders  of  the  respective  diseases. 

Section  2.  Paragraph  1.  The  return  date  on  the  trade  labels  of 
blackleg  vaccine  prepared  from  attenuated  Bacillus  chauveaui,  or 
blackleg  muscle  virus,  shall  be  a  date  not  more  than  one  and  one-half 
years  later  than  the  date  on  which  the  preparation  of  the  product  is 
completed,  without  regard  to  the  filling  of  final  containers. 

Paragraph  2.  The  return  date  on  the  trade  labels  of  anthrax  vac- 
cine prepared  by  the  Pasteur  method  shall  be  a  date  not  more  than 
three  months  later  than  that  on  which  the  preparation  of  the  product 
is  completed  without  regard  to  the  filling  of  final  containers. 

Paragraph  3.  Trade  labels  affixed  to  or  used  in  connection  with  the 
immediate  or  true  containers  of  tuberculin  shall  bear  a  statement 
indicating  the  equivalent  of  Koch's  old  tuberculin  (K.  O.  T.)  con- 
tained in  each  cubic  centimeter,  disk,  etc.,  of  the  product  as  marketed. 
Such  labels  shall  also  bear  recommendations  regarding  the  minimum 
dose  to  be  administered,  and  this  dose  for  subcutaneous  use  shall  be 
not  less  than  the  equivalent  of  0.5  gram  of  Koch's  old  tuberculin. 
Tuberculin  intended  for  subcutaneous,  intracutaneous,  or  cutaneous 
use  shall  be  filtered  through  germ-proof  filters  before  being  marketed. 

Section  3.  The  immunity  unit  for  measuring  the  strength  of 
tetanus  antitoxin  shall  be  10  times  the  least  quantity  of  antitetanic 


serum  necessary  to  save  the  life  of  a  350-<rram  guinea  pig  for  90 
hours  against'  the  official-test  dose  of  the  standard  toxin  furnished 
by  the  Hygienic  Laboratory  of  the  United  States  Public  Health 
Service.  The  number  of  the  immunity  units  recommended  for  the 
prevention  of  tetanus  in  a  horse  shall  be  at  least  500  units. 

REGULATION    21.— ADMISSION    OF    VIRUSES,    SERUMS,    TOXINS,    AND 
ANALOGOUS  PRODUCTS. 

Section  1.  Paragraph  1.  No  virus,  serum,  toxin,  or  analogous 
product  which  has  not  been  prepared,  handled,  stored,  and  marketed 
in  accordance  with  these  regulations,  and  no  virus,  serum,  toxin, 
or  analogous  product  which  is  worthless,  contaminated,  dangerous, 
or  harmful  shall  be  brought  on  to  the  premises  of  an}7  licensed 
establishment. 

Paragraph  2.  Hog-cholera  virus  and  anti-hog-cholera  serum  pre- 
pared by  the  Bureau  of  Animal  Industry  will  be  admitted  to 
licensed  establishments  for  use  as  prescribed  in  these  regulations 
or  as  may  be  approved  by  the  chief  of  bureau. 

Paragraph  3.  Hog-cholera  virus  procured  from  outbreaks  of  hog 
cholera  on  farms  that  are  free  from  other  communicable  diseases 
will  be  admitted  to  licensed  establishments  when  desired  for  use  in 
propagating  a  new  strain  to  be  used  in  inoculating  virus.  Before 
such  virus  is  used  in  the  production  of  simultaneous  virus  -or 
hyperimmunizing  virus,  however,  pigs  weighing  from  30  to  80 
pounds  shall  be  inoculated  therewith  with  the  view  of  determining 
whether  the  purity  and  virulence  of  the  product  are  satisfactory. 
The  virus  should  be  passed  through  pigs  as  described  until  its 
virulence  and  purity  are  satisfactory  or  the  product  should  be 
destroyed. 

Paragraph  4-  Anti-hog-cholera  serum  and  hog-cholera  virus  col- 
lected by  licensed  establishments  and  suitable  for  use  under  these 
regulations  may  be  transported  from  one  licensed  establishment  to 
another  or  between  units  of  the  same  establishment  provided  these 
products  are  properly  packed.  If  said  products  are  not  completed 
and  labeled  as  prescribed  by  these  regulations  they  shall  be  so 
packed  or  iced  that  a  temperature  of  not  more  than  55°  F.  will  be 
maintained  therein  during  transportation  and  the  containers  thereof 
shall  be  sealed  by  a  bureau  employee,  this  seal  to  be  broken  by  such 
an  employee  at  the  point  of  destination. 

THE  VIRUS-SERUM-TOXIN   LAW. 

[Extract  from  "  An  act  making  appropriations  for  the  Department  of  Agriculture  for  the 
fiscal  year  ending  June  thirtieth,  nineteen  hundred  and  fourteen,"  approved  March  4, 
1913   (37  Stat,  832).] 

That  from  and  after  July  first,  nineteen  hundred  and  thirteen,  it  shall  be 
unlawful  for  any  person,  firm,  or  corporation  to  prepare,  sell,  barter,  or  exchange 
iD  the  District  of  Columbia,  or  in  the  Territories,  or  in  any  place  under  the 
jurisdiction  of  the  United  States,  or  to  ship  or  deliver  for  shipment  from  one 
State  or  Territory  or  the  District  of  Columbia  to  any  other  State  or  Territory 
or  the  District  of  Columbia,  any  worthless,  contaminated,  dangerous,  or  harm- 
ful virus,  serum,  toxin,  or  analogous  product  intended  for  use  in  the  treatment 
of  domestic  animals,  and  no  person,  firm,  or  corporation  shall  prepare,  sell, 
barter,  exchange,  or  ship  as  aforesaid  any  virus,  serum,  toxin,  or  analogous 
product  manufactured  within  the  United  States  and  intended  for  use  in  the 
treatment  of  domestic  animals,  unless  and  until  the  said  virus,  serum,  toxin,  or 


35 

analogous  product  shall  have  heen  prepared,  under  and  in  compliance  with 
regulations  prescribed  by  the  Secretary  of  Agriculture,  at  an  establishment 
holding  an  unsuspended  and  unrevoked  license  issued  by  the  Secretary  of 
Agriculture  as  hereinafter  authorized.  That  the  importation  into  the  United 
States,  without  a  permit  from  the  Secretary  of  Agriculture,  of  any  virus,  serum. 
toxin,  or  analogous  product  for  use  in  the  treatment  of  domestic  animals,  and 
the  importation  of  any  worthless,  contaminated,  dangerous,  or  harmful  virus, 
serum,  toxin,  or  analogous  product  for  use  in  the  treatment  of  domestic  animals, 
are  hereby  prohibited.  The  Secretary  of  Agriculture  is  hereby  authorized 
to  cause  the  Bureau  of  Animal  Industry  to  examine  and  inspect  all  viruses, 
serums,  toxins,  and  analogous  products;  for  use  in  the  treatment  of  domestic 
animals,  which  are  being  imported  or  offered  for  importation  into  the  United 
States,  to  determine  whether  such  viruses,  serums,  toxins,  and  analogous  prod- 
ucts are  worthless,  contaminated,  dangerous,  or  harmful,  and  if  it  shall  appear 
that  any  such  virus,  serum,  toxin,  or  analogous  product,  for  use  in  the  treat- 
ment of  domestic  animals,  is  worthless,  contaminated,  dangerous,  or  harmful, 
the  same  shall  be  denied  entry  and  shall  be  destroyed  or  returned  at  the  expense 
of  the  owner  or  importer.  That  the  Secretary  of  Agriculture  be.  and  hereby  is. 
authorized  to  make  and  promulgate  from  time  to  time  such  rules  and  regula- 
tions as  may  be  necessary  to  prevent  the  preparation,  sale,  barter,  exchange, 
or  shipment  as  aforesaid  of  any  worthless,  contaminated,  dangerous,  or  harm- 
ful virus,  serum,  toxin,  or  analogous  product  for  use  in  the  treatment  of  domestic 
animals,  and  to  issue,  suspend,  and  revoke  licenses  for  the  maintenance  of 
establishments  for  the  preparation  of  viruses,  serums,  toxins,  and  analogous 
products,  for  use  in  the  treatment  of  domestic  animals,  intended  for  sale,  barter, 
exchange,  or  shipment  as  aforesaid.  The  Secretary  of  Agriculture  is  hereby 
authorized  to  issue  permits  for  the  importation  into  the  United  States  of  viruses, 
serums,  toxins,  and  analogous  products,  for  use  in  the  treatment  of  domestic 
animals,  which  are  not  worthless,  contaminated,  dangerous,  or  harmful.  All 
licenses  issued  under  authority  of  this  Act  to  establishments  where  such  viruses, 
serums,  toxins,  or  analogous  products  are  prepared  for  sale,  barter,  exchange. 
or  shipment  as  aforesaid,  shall  be  issued  on  condition  that  the  licensee  shall 
permit  the  inspection  of  such  establishments  and  of  such  products  and  their 
preparation :  and  the  Secretary  of  Agriculture  may  suspend  or  revoke  any  per- 
mit or  license  issued  under  authority  of  this  Act,  after  opportunity  for  hearing 
has  been  granted  the  licensee  or  importer,  when  the  Secretary  of  Agriculture 
is  satisfied  that  such  license  or  permit  is  being  used  to  facilitate  or  effect  the 
preparation,  sale,  barter,  exchange,  or  shipment  as  aforesaid,  or  the  importa- 
tion into  the  United  States  of  any  worthless,  contaminated,  dangerous,  or  harm- 
ful virus,  serum,  toxin,  or  analogous  product  for  use  in  the  treatment  of 
domestic  animals.  That  any  officer,  agent,  or  employee  of  the  Department  of 
Agriculture  duly  authorized  by  the  Secretary  of  Agriculture  for  the  purpose 
may.  at  any  hour  during  the  daytime  or  nighttime,  enter  and  inspect  any  estab- 
lishment licensed  under  this  Act  where  any  virus,  serum,  toxin,  or  analogous 
product  for  use  in  the  treatment  of  domestic  animals  is  prepared  for  sale,  barter, 
exchange,  or  shipment  as  aforesaid.  That  any  person,  firm,  or  corporation 
who  shall  violate  any  of  the  provisions  of  this  Act  shall  be  deemed  guilty  of  a 
misdemeanor,  and  shall,  upon  conviction,  be  punished  by  a  fine  of  not  exceeding 
$1,000  or  by  imprisonment  not  exceeding  one  year,  or  by  both  such  fine  and 
imprisonment,  in  the  discretion  of  the  court. 


o 


UNIVERSITY  OF  FLORIDA 

iim 

3  1262  08859  2828 


